Resources on Subject Radiation Management of Pregnant Patients and Pregnant Staff Louis K. Wagner, Ph.D. Department of Radiology http://www.uth.tmc.edu/radiology/web_pub.html © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 1 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. Educational objectives of this course Assessing risks to a conceptus at < 0.25 Gy • • Depends on gestation age • Depends on dose • Requires attention to communication for proper assessment • Requires attention to records for proper assessment • Perspective is always a matter of science, opinion, and presentation • • To develop a working perspective on the risks involved with radiation exposure to the pregnant individual. To itemize procedural tasks necessary to properly manage and monitor radiation delivery. To review professional counseling and the role of the medical physicist in the management of patients and personnel. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 3 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 2 4 1 Risks and gestation age Risks and gestation age • In obstetrics, gestation age is usually dated on menstruation, not conception. • Menstrual age may be based on tests or on menstrual history, and conception age may differ depending on patient’s menstrual patterns and health. • Roughly speaking menstrual age and gestation age are the same thing and both = conception age + 2 weeks. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. Lesson: Before discussing risks, be sure to determine the age of a conceptus according to a common reference – menstruation or conception. Two weeks can make an enormous difference in risk assessment. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 5 6 Potential Risks at Doses under 200 mGy Risks and gestation age Risk Probable single-dose threshold (mGy) Vulnerable Postconception age Mechanisms for effects: Misrepaired sub-cellular changes – stochastic in nature, include cancer and heritable genetic effects. Cell death – detectable effects due to cell death have a practical threshold below which the effect is not observed, include all forms of malformation. © 2003 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 7 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 8 2 Potential Risks at Doses under 200 mGy Potential Risks at Doses under 200 mGy Risk Risk Cancer Probable single-dose threshold (mGy) Vulnerable Postconception age ~0 All stages?? Cancer Early Termination © 2003 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. Probable single-dose threshold (mGy) Vulnerable Postconception age ~0 All stages?? ~100 <2wks (postconception) © 2003 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 9 Potential Risks at Doses under 200 mGy Potential Risks at Doses under 200 mGy Risk Risk Cancer Probable single-dose threshold (mGy) Vulnerable Postconception age ~0 All stages?? Early Termination ~100 <2wks (postconception) Malformation ~100 >2, <9 wk Cancer Early Termination © 2003 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 11 Probable single-dose threshold (mGy) 10 Vulnerable Postconception age ~0 All stages?? ~100 <2wks (postconception) Malformation ~100 >2, <9 wk Cretinism I-131 After thyroid function commences ~ 8 wk © 2003 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 12 3 Potential Risks at Doses under 200 mGy Potential Risks at Doses under 200 mGy Risk Risk Cancer Probable single-dose threshold (mGy) Vulnerable Postconception age ~0 All stages?? Early Termination ~100 <2wks (postconception) Malformation ~100 >2, <9 wk Cretinism I-131 Small head size > 50 After thyroid function commences ~ 8 wk >2, <16 wk Vulnerable Postconception age ~0 All stages?? Early Termination ~100 <2wks (postconception) Malformation ~100 >2, <9 wk Cretinism I-131 Cancer © 2003 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. Probable single-dose threshold (mGy) 13 Small head size > 50 After thyroid function commences ~ 8 wk >2, <16 wk IQ deficit ~100 >7, <16 wk © 2003 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 14 Potential Risks at Doses under 200 mGy Risk Cancer Probable single-dose threshold (mGy) Vulnerable Postconception age ~0 All stages?? Early Termination ~100 <2wks (postconception) Malformation ~100 >2, <9 wk Cretinism I-131 Small head size > 50 After thyroid function commences ~ 8 wk >2, <16 wk IQ deficit ~100 >7, <16 wk Severe mental retardation ~150 >7, <16 wk An exposure higher than 0.4 mGy (to the thyroid) during gestation occurred in mothers of low-birth-weight infants. Retrospective study: women with low birth weight babies are more likely to have had dental x-rays that resulted in more than 0.4 mGy to the thyroid. © 2003 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 15 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 16 4 Risks? What Risks? Risks? What Risks? Scientists present data in a variety of quanitiative ways that are useful to scientists, but are frequently misused when communicating to a general audience. Mrs. Smith, the pelvic CT study for your kidney Mrs. Smith, I know that you have heard that the infection that you had two weeks ago, before we radiation you received froma your CT examination Does quantifying risk give realistic or a distorted knew you were pregnant, has perhaps doubled the may have increased the chances thatshould your child perspective on how much someone be risk that your child will develop cancer before age 18. could develop cancer, concerned about it? but this risk is very small and the likelihood of a normal outcome is nearly the same as it is for any child. Without the radiation 99.7%remain free of cancer. In your case this might be around 99.4%. Relative risk versus absolute risk ---- what is the difference in perspective? Which explanation most appropriately conveys the risk? Both are quantitatively correct. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 17 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 18 19 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 20 Radiation and healthy children Conceptus dose (mGy) Probability of no malformation (%) Probability of no cancer before age 19 y (%) 0 97 99.7 0.5 97 99.7 1.0 97 99.7 2.5 97 99.7 5 97 99.7 10 97 99.6 50 97 99.4 100 ~ 97 99.1 Risk of cancer mortality ~1/17,000 per mGy dose to conceptus From ICRP # 84 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 5 My clinical guidelines on risks for patients My clinical guidelines on risks for patients • Keep benefit/risk as high as reasonable achievable; • At doses < 50 mGy to conceptus, risk results in minimal potential harm, but should be avoided if possible; • At doses between 50 and 100 mGy risk is still minimal on a measureable basis, but microscopic changes in the cerebral cortex have been documented when radiation is delivered in vulnerable periods for cerebral development. • At doses above 100 mGy risk thresholds are reached and risks increase as dose increases. • See ICRP 84 for details on risk. • Keep benefit/risk as high as reasonable achievable; • At doses < 50 mGy to conceptus, risk results in minimal potential harm, but should be avoided if possible; • At doses between 50 and 100 mGy risk is still minimal on a measureable basis, but microscopic changes in the cerebral cortex have been documented when radiation is delivered in vulnerable periods for cerebral development. • At doses above 100 mGy risk thresholds are reached and risks increase as dose increases. • See ICRP 84 for details on risk. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 21 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. My clinical guidelines on risks for patients My clinical guidelines on risks for patients • Keep benefit/risk as high as reasonable achievable; • At doses < 50 mGy to conceptus, risk results in minimal potential harm, but should be avoided if possible; • At doses between 50 and 100 mGy risk is still minimal on a measureable basis, but microscopic changes in the cerebral cortex have been documented when radiation is delivered in vulnerable periods for cerebral development. • At doses above 100 mGy risk thresholds are reached and risks increase as dose increases. • See ICRP 84 for details on risk. • Keep benefit/risk as high as reasonable achievable; • At doses < 50 mGy to conceptus, risk results in minimal potential harm, but should be avoided if possible; • At doses between 50 and 100 mGy risk is still minimal on a measureable basis, but microscopic changes in the cerebral cortex have been documented when radiation is delivered in vulnerable periods for cerebral development. • At doses above 100 mGy risk thresholds are reached and risks increase as dose increases. • See ICRP 84 for details on risk. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 23 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 22 24 6 My clinical guidelines on risks for patients My clinical guidelines on risks for workers • Keep benefit/risk as high as reasonable achievable; • At doses < 50 mGy to conceptus, risk results in minimal potential harm, but should be avoided if possible; • At doses between 50 and 100 mGy risk is still minimal on a measureable basis, but microscopic changes in the cerebral cortex have been documented when radiation is delivered in vulnerable periods for cerebral development. • At doses above 100 mGy risk thresholds are reached and risks increase as dose increases. • See ICRP 84 for details on risk. • Keep benefit/risk as high as reasonable achievable; • Carcinogenic risk is only important risk; • Manage all benefit/risk from the start of employment. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 25 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 26 Procedures to Manage Risks ------ Procedural Tasks Be Prepared Prepare policies and procedures for all employees and have special policies regarding pregnant employees; Advise workers about the radiation environment in which they will be working, the likely doses to which they will be exposed, the regulatory philosophy about their exposures and the measures that can be taken to optimize their benefit/risk; Prepare policies and procedures for pregnant patients; Advise medical personnel about the need to screen for pregnancy and advise them on how it must be done and the procedures to implement the policies. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 27 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 28 7 It would be nice if the sign mentioned that this must occur before the patient has the examination! This would be better phrased as “…before any medications, inocculations or tests are started.” © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 29 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 30 31 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 32 Procedures to Manage Risks Prepare-screen Policies and procedures on screening How to screen Ages to screen Exams for which screening applies Minors and guardians Actions if pregnant or potentially pregnant. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 8 {Potential} Guidelines for Our Hospital regarding the radiography and pregnancy in girls and women from the ages of 12 – 50 years who are to undergo x-rays of the abdomen, pelvis or radionuclide studies. •Know and understand the policies of Our Hospital regarding screening procedures for potential pregnancy in women between the ages of 12 and 50 years. •Never perform the screening interrogatories in an area where members of the public are present or where there are other individuals who are not essential to the procedure. •Always be polite when escorting a patient to the examination suite. •When a guardian is present:: If a guardian is with the patient who is between 12 – 17 years of age and the guardian does not ask to attend the procedure, then escort the patient to the procedure room. If the guardian requests to attend the procedure, advise the guardian that that is possible but that you will first have to prepare the patient privately for the procedure. Advise the guardian that this is a matter of medical protocol and that the guardian will be asked to attend the examination once the patient is ready. If the guardian objects, call the radiologist. If the guardian agrees, then proceed to escort the patient to the examination suite. •When in the privacy of the examination room or in a very soft tone of voice when at the bedside of the patient, address the patient as follows: “Before we proceed with your x-rays (or scan) there are few questions I must ask you. These questions are of a personal nature but are medically necessary before we can proceed. We need your full and open cooperation in this matter. Is that OK?” (If “not OK”, call the radiologist.) •When the patient consents to this introductory statement, proceed to ask: “My first question is: Could you be pregnant?” •Write the response in the patient’s record and proceed to the next question: “The last question is: What was the date of your last normal and complete menstrual cycle?”(The words “normal and complete” are necessary because women in early pregnancy can have minor discharge as a result of implantation.) •If a young patient does not appear to understand the question, call the radiologist. Write the response to this question in the record and then politely thank the patient for her cooperation. •Now proceed to carry out the appropriate actions as outlined in the policies and procedures. If it is OK to proceed with the examination and a guardian is waiting, send for the guardian to attend the procedure. If there is some delay due to a potential for pregnancy, advise the guardian that the radiologist is consulting with the referring physician to determine the most proper examination to perform. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 33 Can the results of a pregnancy test be used in lieu of screening interogatories? 34 {Potential} Guidelines for Our Residents in Radiology on the Management and Counseling of Pregnant Patients Who Require Diagnostic X-Ray Imaging of the Abdomen or Pelvis, Radionuclide Studies, or Fluoroscopically Guided Therapeutic Procedures •Know and understand the policies of Our Hospital regarding screening of women between the ages 12 and 50 years for pregnancy prior to diagnostic x-ray imaging of the abdomen or pelvis, radionuclide studies, and fluoroscopically guided therapeutic procedures. •Any life-saving emergency procedure should be done without delay, regardless of pregnancy. •For patients known to be pregnant, reasonable consideration must first be given to alternative examinations that do not require the use of ionizing radiation, i.e., ultrasound or MR. •If an alternative examination is not possible, consider modifying the examination to obtain an adequate diagnosis. Or, consider another type of x-ray examination that uses less radiation than the one ordered. Such a modification must not compromise the diagnostic adequacy, lest the study need to be repeated and unnecessarily expose the patient to even more radiation. •Verbally counsel the patient about the need for the study. Advise her that a benefit-risk assessment has been made and, in the best medical judgment of the physicians, the medical benefits of performing the examination outweigh any potential risks to the child. •For single pass CT studies of the abdomen-pelvis, the dose to the conceptus is not likely to exceed 4 rad (40 mGy) for studies performed at proper technique and is likely to be less than this. For this level of dose, there are no known risks to the development of the child. The only potential risk is for radiation-induced neoplasm (including cancer) that may develop later in life. This risk is very small and the likelihood of this not occurring exceeds 99% of the normal likelihood of remaining healthy. For pelvic CT, dosimeters should be placed anteriorly and posteriorly on the patient at the level of the conceptus if time permits. Obtain them from the radiation safety office. •In pregnant patients who require CT of the pelvis, a single pass of the pelvis should be all that is needed. Any request for dual pass must be carefully and cautiously considered. If two or more passes over the pelvis are involved, a more involved assessment of dose and risk is required. •All planar diagnostic procedures deliver much less radiation to the baby than single-pass CT, except on occasion for fluoroscopy of the pelvis. Therefore there are no additional concerns for planar studies. •For pelvic angiography dosimeters should be placed anteriorly and posteriorly on the patient at the level of the conceptus. Obtain them from the radiation safety office. •Notate the results of all counseling in the patient’s chart. My policy is this: Pregnancy tests are not required and are not a part of the standard of care for radiography. If results of any recent pregnancy test are positive for pregnancy, consult with the radiologist before proceeding. If results of any recent pregnancy test are negative, disregard the results and proceed with interrogatories. Pregnancy tests are required for all administrations of I-131 and therapeutic radionuclides administered IV or per os. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 35 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 36 9 Procedures to Manage Risks Prepare-Monitor doses Know doses ahead of time: Collect data at routine physics inspections regarding conceptus doses from particular examinations Educate fluoroscopists of management of doses, especially during pregnancy Report conceptus doses for average patient from single pass CT of the pelvis Take action if protocols deliver unnecessarily high doses. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. Measure © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 38 39 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 40 Corrected kV mA Time (s) Slice Interval (mm) Helical Pitch FOV (cm) Dose(mR) Dose (mrad) Head (holder) 120 200 1 5 No 1 25 81.4 2920 Head (holder) 140 170 1 5 Yes 1 25 98.1 3519 Head (holder) 140 170 1 5 No 1 25 98.1 3519 Head (holder) 120 300 1 5 No 1 25 122 4376 Head (holder) 120 280 1 5 No 1 25 114 4089 Head (holder) 120 170 1 5 No 1 25 69.2 2482 Head (holder) 120 200 1 10 No 1 25 161 2888 Head (holder) 120 200 1 7 No 1 25 113 2895 Head (holder) 120 200 1 3 No 1 25 51.3 3067 Head (holder) 120 200 1 1 No 1 25 17.8 3193 Table (Head ph) 120 250 1 5 No 1 36 104 3731 Conceptus 120 250 1 5 No 1 36 104 2574 Exam 37 Note: conceptus dose is based on contiguous scanning, divide by pitch to obtain dose when pitch different from 1.0. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 10 Pregnant Patient My guidelines for workers Prepare-Advise Pregnant Patient • Prepare policies and procedures for your facility • Counseling on risks should occur before pregnancy occurs (e.g., at pre-employment, orientation, or in educational setting); • Dose monitoring should start before employee becomes pregnant; • Employee is advised at pre-employment, oreintation, or in educational setting, that she must report a pregnancy to the RSO before any special measures can be taken to assist her in optimizing her benefit/risk for her condition; • Male employees are included in counseling on risks and advised of policy about their obligation to pitch in when readjustment of schedules may be necessary. Not for patients! © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 41 Professional Counseling—the patient © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 42 •To: Dr. Noname •CONFIDENTIAL •Re: Shesa Patient •On 2 May 2005 I was provided by your assistant , Dr. Resident, documentation on radiologic examinations that the above patient underwent on 30 February 2005. These included : •One nuclear medicine bone scan involving 21.3 mCi of 99m-Tc HDP •Several CT scans of the following: •Scout image (missing, but presumably of the head) •CT imaging of the head involving a volume about 13-cm long of contiguous slices consisiting of 3-mm and 5-mm thickness at 3-mm and 5-mm intervals. Technique was 140 kVp, 170 mA, 2 seconds per rotation. •Scout image of the torso, excluding the uterus. •CT scan without contrast involving a volume about 23-cm long of contiguous 10-mm images acquired at 10-mm intervals. Technique was 120 kVp, 180 mA, 1 second per rotation. Volume was from top of hips to just above the diaphragm. •First phase contrast involving a volume spanning 32 cm in length from about 5 cm above pelvic bone to superior aspect of lungs. Technique was 120 kVp, 180 mA, 1 second per rotation, pitch of 2:1. •Second contrast phase spanning a volume of 26 cm in length from top of hip bone to top of diaphragm. Technique same as above. •Third phase contrast from about 3-cm above hip bone for 22 cm. •Another scout (missing, presumably of the head) •A head series, I believe (missing) •A retrospective series (missing) •This patient is an average size patient with abdominal dimensions of about 24 cm x 30 cm. It is my understanding that the patient was about 4 weeks from her last LMP when these studies were acquired. None of the above series directly irradiated the uterus. Therefore the entire dose from the CT scans was from scattered radiation. The most inferior scan was about 10 cm from the top of the uterus. Please note that I do not have dosimetry information about the CT scanner in question. Most of these GE scanners result in similar outputs, but to provide a more confidient set of calculations, I would need to have dose data on the scanner in question. Based on experience with another GE scanner, I estimate the dose to the uterine area to be about 0.76 rad (7.6 mGy). Providing for a conservative potential error of a factor of two in the estimate, the dose would have been below 1.5 rad (15 mGy). The majority of the dose to the uterus is from radioactivity in the uterus and in the urinary bladder from the Nuclear bone scan. Caution : Always separate your medical physics services from the physician’s medical care services. I strongly recommend that it be made perfectly clear to all parties ahead of time that as a medical physicist you are not a medical doctor and all medical advice should be requested of a responsible physician. • It is the physician’s role to counsel pregnant patients ahead of time; • Physicist monitors doses in real-time if appropriate; • Physicist determines doses when necessary and files a dose report with the appropriate physician; • Report to your client along proper channels; • Consult with referring physicians or radiologists on information they request about dose and risk; • Physician to file information in patient’s record. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. Woman Resident 43 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 44 11 My guidelines for counseling pregnant workers • Benefits are decided by the worker, not the employer--worker decides if she wants to avoid radiation areas altogether; • Review history of pelvic exposures and advise of nature of risk and risk levels; • Counsel on behavior to keep doses well managed; • Provide extra shielding if desired; • Provide realtime monitors if desired. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 45 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 46 6 lbs. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 47 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 48 12 10 lbs. 14 lbs. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 49 © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 50 Educational objectives of this course To develop a working perspective on the risks involved with radiation exposure to the pregnant individual. To itemize procedural tasks necessary to properly manage and monitor radiation delivery. To review professional counseling and the role of the medical physicist in the management of patients and personnel. © 2004 by Louis K. Wagner, Ph.D. Reproduction not permitted without the written consent of the author. 51 13