Center for Advanced Computed Tomography Imaging Services
(CACTIS)
Human CT Research Application Form
CACTIS CODE:
DATE:
IRB #
____ Filled out by CACTIS coordinator.
If applicable, UPCC #
New Submission
Modification/revised
Renewal
Protocol Title:
Brief description of the study protocol:
Brief description of purpose and type of CT scan requested:
Principal Investigator:
Address:
Office number:
Email address:
Pager number:
Study Contact:
Address:
Office number:
Pager number:
Email address:
(Must provide either office or pager number for either PI or study coordinator)
Study Coordinator (if different from contact):
Address:
Office number:
Pager number:
Email address:
(This should be the person to be contacted on the day of the study if the CT department has questions on the day of the CT or if
the scheduling department has questions)
Name of Radiology Faculty Member* involved with this research:
*Must be listed as a Sub-investigator if the CT scans involve special evaluations.
Role of radiologist: Contact/consult only:
or Sub-investigator:
For research reports that require review for incidental findings only, see the reader service fee, section: 12.
************************************************************************************************
1) Is this study funded? YES
NO
Have you applied for limited PRODEV funds?
FUNDING SOURCE:
NIH/NCI Grant:
Grant number:
Sponsor:
OTHER (please provide explanation):
Department Org #:
26 digit BEN ACCOUNT**:
**Account number must be received by CACTIS prior to full approval. Contrast is not included in PRODEV accounts
and will be billed to the above 26 digit account number.
Business Administrator Contact:
Email:
Phone:
PI Signature: __________________________________________
(by signing the PI acknowledges that the information
provided to CACTIS is accurate to the best of his/her knowledge and that CACTIS will deduct the cost of the CT scans,
and/or other services from the above account if using the service center for billing. A copy of this form with an original
signature must be on file, emailed, prior to full approval) the person completing this form should also print or sign the last page.
The PI signature is still needed above.
***********************************************************************************************
Page 1 of 8
Version: 2015-11-12
2) Has this study been approved by the IRB?
YES
NO
Pending
Other:
If yes, please forward a current copy of the IRB approval letter and dated consent form. If no, approval will be
withheld pending the receipt of the above documents.
3) Has this study been approved by Radiation Safety?
YES
NO
Pending
Other:
(A copy of the radiation safety approval letter must be on file prior to full CACTIS approval)
4) Does the project involve the testing of investigational drugs or devices?
If yes, provide Name of DRUG or DEVICE:
IND# or IDE #:
Name of Manufacturer:
YES
NO
5) Does the protocol require optional or mandatory biopsies for research which may need CT guidance or other
imaging guidance?
YES
(If yes, contact the CACTIS coordinator or click the link to request appendix 1-biopsy form)
NO
Link to appendix 1-research biopsy form:
6) CT Research Scans
Radiology exam codes and CPT codes
Use link to the Radiology exam code lookup: http://uphsnet.uphs.upenn.edu/ExamCodeLookup
The correct codes are under the NEW UNIFIED EXAM CODES column.
Contact Deborah Arnold for the codes if needed.
List the type of CT Study (example: high resolution chest CT):
List Radiology exam code (s):
If unsure, radiology exam codes can be determined at the time of CACTIS review.
(Contact: Deborah Arnold, CACTIS Coordinator, 215-662-4595 or Laura Posey, CT Manager 215-614-1439)
A. Are you using IV contrast?
YES
NO
cost: $25/per administration
B. Are using oral contrast?
YES
NO
cost: $10/per administration
C. Bill grant/sponsor for contrast?
YES
NO
(if no explain)
7) List the CT location(s) UPHS site(s) where research CT scans are to be performed?
Location(s):
8) How much scanner time will be necessary per session?
Most CTs are completed within one ½ hr. session.
Biopsy procedures and oral contrast studies may take 1 hour or longer.
Page 2 of 8
Version: 2015-11-12
Describe research CT scan schedule per patient according to the protocol, identify the CT scans that are
research only time points:
Are there any time limits to the scheduling availability of the subject? YES
NO
Describe limitations:
Special scheduling times or large volumes of patients on the same day will need to be negotiated with
Laura Posey, CT Manager 215-614-1439
CACTIS Service Center Costs - CT scans are billed by ½ hr. session.
$350 for industry sponsored studies
$250 for government and investigator initiated sponsored studies
Non-service center rates (FAMILY accounts): Contact Ron Bright
9) Will the CT study scans use: HUP PROTOCOL
CUSTOM / SPONSOR PROTOCOL
Other
NOTE: Please fill out protocol page for all custom protocols or submit the CT protocol imaging guidelines.
10) Will studies need to be placed on a CD or DVD?
CDs for CACTIS service center accounts:
YES
NO
Note: Contact the CACTIS coordinator for more information.
CDs for Non- service center accounts: contact the radiology file room or Cathy Oliva of IOD via
cathy.oliva@uphs.upenn.edu for a work order. Account set-up takes two weeks; CDs are picked up at the
ground floor radiology imaging file room. The cost of burning images to a CD is $5 per CD
Note: Currently, the radiology imaging library de-identifies the images and only puts the case number on the
CD labels, make sure this is OK with the sponsor.
SFTP (secure file transfer protocol accounts: Your sponsor may provide you with software that allows you to
easily de-identify the images before using sFTP uploading of images from your personal computer, but you
may still require a CD to do this.
The transfer of imaging data from Penn to off-site image management companies is the responsibility of the
investigator and the research study personnel.
Do you need assistance with this?
YES
NO
11) Does your study require a report?
YES
NO
Radiologist responsible for image evaluation is:
Is the report to be documented in the medical record?
Is the report to be documented only in the research files?
(In this instance you should discuss this requirement with a radiologist.)
Radiology reports are not automatically provided as part of the research service. This cost is not
included as part of the CT scan. If you would like to have a report generated you must arrange this
with the radiologist on your study or use one of the reader fees. In some protocols it is more
beneficial to have only one radiologist read all of the research exams for consistency in the
reporting. Compensation for this effort is negotiated separately between the radiologist and the PI.
Page 3 of 8
Version: 2015-11-12
It is strongly recommended that reports of research images be recorded in the medical
record, but there are times when you need a report that is only documented in the research
record. This should be discussed with a radiologist.
Special evaluations or measurements which are research study specific, require a radiologist to be
part of the research study team, the radiologist must be listed as a sub-investigator.
12) Will this study use the reader services?
YES
NO
(If no, skip to 13s)
The reader service provides a basic clinical report and/or a report when screening for incidental
findings is required.
Policy: A radiologist must review the images officially or unofficially for incidental findings when
the images are of diagnostic quality that could reveal incidental findings that are unexpected and
unrelated to the research question. The reader service may not be used when research specific
evaluations or measurements are required per the protocol.
When may the reader service be used?
A. When a patient is under active treatment at Penn and the images are being sent off site for analysis by
the research team, a report for incidental findings by a Penn radiologist is required for incidental
findings.
B. When a patient is not under active treatment at Penn, but is in a research study and is not receiving
similar imaging for cancer or other conditions and the research images are of diagnostic quality that
could reveal unexpected incidental findings, then a report for incidental findings is also required.
Who reads for the reader service? Any radiologist reading on the day of the exam, based on the
anatomic reader sections listed below.
READER SERVICE FEES - please check all that apply.
Neuro
$55
Body
$100 (abdomen and pelvis)
Cardiac
$55
Chest
$55
Musculoskeletal
$55
Cost of CT scans using CACTIS service center billing is posted on the website.
13) Patient Enrollment
Total anticipated enrollment:
Will the subject be:
inpatient
Study duration:
outpatient
both?
14) Patient safety:
Will pregnant subjects be excluded from this protocol?
YES
NO
If yes, then it is the responsibility of the study team to determine and document in their records nonpregnancy.
The CT technologist will only ask if there is a possibility of pregnancy.
CACTIS no longer requires urine pregnancy test 24 hours prior to the CT scan if the study team is already
performing these tests to exclude pregnancy such as is common with new drug studies and
chemotherapeutic agents, etc.
Page 4 of 8
Version: 2015-11-12
Policy: If the protocol does not exclude pregnancy, then a pregnancy test is required 24 hours prior
to the CT scan to rule out pregnancy. CACTIS excludes pregnant women form research studies
because of the possible harmful effects to the fetus from the x-radiation.
Is it possible that the patient will have motor or mental deficits? YES
Will the patients need monitoring*?
YES
NO
NO
If yes, explain the monitoring that will be necessary and who will monitor the subject and record any
adverse events post CT scan or CT procedure:
*Patient monitoring is the responsibility of the study team.
Policy: The CT staff will NOT monitor study patients once they leave the CT scan room. All patients
receiving IV contrast must remain in the department and be monitored for at least 30 minutes post
contrast to rule out delayed contrast adverse events.
Do you need radiology research staff to assist with this requirement? YES
NO
There is a fee for this service through radiology research RADCORE. Contact Kathleen Thomas
for rates.
Does your consent form have the standard language required for CT scans, IV contrast, biopsy risks etc.,
refer to the CACTIS website? YES
NO
Unsure
contact the CACTIS coordinator (215-662-4595)
Consent form language and more information may be found on the CACTIS website:
http://www.uphs.upenn.edu/radiology/research/labs/cactis/
15) CT CONTRAST AGENTS – Standard CT contrast agents currently used at HUP/Perelman
IV contrast agent: ISOVUE 370, cost $25/per injection
Oral contrast agent: Redicat2, cost $ 10/ per single use
Other:
Will contrast agents be required?
YES
NO
IV contrast HUP/Perelman: ISOVUE 370
YES
NO
Oral contrast agent used at HUP/Perelman: Redicat2
List other contrast agents that will be used
YES
NO
Is this contrast agent experimental?
************************************************************************************************
Page 5 of 8
Version: 2015-11-12
16) CT IMAGING
YES
NO
Will the CT technologists need training?
If yes, describe type of training and how much time is needed for this?
YES
NO
YES
NO
Are site qualification forms and/or CT phantom/test images required?
The cost is $150/per phantom or test image scan
Does your protocol require that the same CT scanner be used for all follow-up CTs?
YES
NO
Are you submitting a custom CT protocol?
This section intentionally left blank
Please add important instructions or notes for the radiologist or technologist or add any questions you need
answered before the CACTIS review.
Free text:
continued
Page 6 of 8
Version: 2015-11-12
CT SCAN PROTOCOL PAGE Routine Clinical Protocol
Custom Protocol
Custom CT Scan Protocol Table
Please provide parameters in the table below. If your study includes a separate scanning protocol for the CT, please fill
in the below information and attach a copy of the scanning protocol to this application.
kV
mAs
Slice collimation
Slice width
Feed/Rot.
Rot. Time
Recon. Kernel
Increment
Direction
Coverage
Oral contrast
IV contrast
IV contrast
injection rate
Scanning Delay
Dose reduction
NOTE: Post-processing, including sagittal or coronal multi-planar reformatting, etc., is done automatically on the CT
console. Custom protocols must be loaded on specific scanners; this is determined at time of CACTIS review.
Is standard post processing required?
List the reconstructions:
Bone
Coronal MPR:
Sagittal MPR:
Axial
MPR:
YES
Are additional reconstructions required?
Please provide explanation:
YES
NO
don’t know
Soft tissue
NO
Any additional post-processing will be charged a separate rate. This rate must be negotiated and signed off
on prior to the study start date.
Name of Person Completing this form:
Date:
Page 7 of 8
Version: 2015-11-12
*****************************************************************************************************************
Instructions: Submit this application via email to the CACTIS coordinator as two documents, one
formatted as a Word document, the second with PI signature should be saved as a PDF:
Deborah.Arnold@uphs.upenn.edu
More information and standard consent form language can be found on the CACTIS website
http://www.uphs.upenn.edu/radiology/research/labs/cactis/
CACTIS REVIEW
CACTIS meets usually meets the third Thursday of each month, sometimes this is date must be moved to accommodate the
members.
*****************************************************************************************************************
This section completed by CACTIS Committee Reviewers
Date Received:
DATE of Review:
Radiology exam codes and cpt codes. Use link to the Radiology exam code lookup:
http://uphsnet.uphs.upenn.edu/ExamCodeLookup
The correct codes are under the NEW UNIFIED EXAM CODES column.
Contact Deborah Arnold for the codes if needed.
List Radiology exam code (s):
Documents submitted:
Reviewers comments: __________________________________________
Page 8 of 8
Version: 2015-11-12