[Facility’s Letterhead]
Dear [Referring Physician]:
As you may know, several of your patients are participants in an ongoing clinical trial,
“Screening Breast Ultrasound for High-Risk Women”, funded by a unique partnership
between the National Cancer Institute and the Avon Foundation and coordinated by the
American College of Radiology Imaging Network (ACRIN). I am writing to request
your assistance with the referral of those patients into the trial’s MRI substudy that
was recently activated at our center.
Each participant in the ongoing ultrasound trial will have had both mammography and
whole breast ultrasound at 0, 12, and 24 months as part of that study. As participants
approach the 24 month time point, they are now being invited to participate in a substudy
to evaluate the role of contrast-enhanced MRI of the breast(s) in screening high-risk
women. Your help referring study patients for the MRI component would be greatly
appreciated. The MRI will be billed to the patient’s insurance; should the patient be
uninsured or have an extremely high deductible, the Avon Foundation has granted us
limited funds to assist with this issue due to the importance of the study. Most insurance
carriers are covering MRI for high-risk screening, though indications are evolving.
MRI requires injection of a salt solution of gadolinium. Some patients are claustrophobic
and may benefit from a small dose of ativan or valium. In prior studies, from 7-18% of
women who had an MRI needed a biopsy, with 24% of such biopsies showing cancer. A
short interval follow-up MRI might also be recommended. Background information
about the trial follows, and I am enclosing a copy of the letter that has been provided to
your patient describing the MRI study.
If you have any questions, please feel free to contact me at [contact information]. Thank
you for your time and interest.
Sincerely yours,
MRI Substudy Background
In women with dense breast tissue, from 30 to 50% of cancers are missed on
mammography, even when digital mammography is used. Both screening ultrasound and
MRI have been shown to find small invasive cancers not seen on mammography. Some
cancers can only be seen on MRI. In recent studies from Canada and Europe in high-risk
women, combined mammography and ultrasound detected only 53% of cancers and the
combination of mammography and MRI detected 92% of cancers (1-5). Where it could
be evaluated, women in the group who had MRI had cancers that were smaller and more
likely node negative than those who did not have MRI (2). Risk factors varied in these
studies, but all women enrolled in the ongoing screening ultrasound trial meet “high-risk”
criteria used in at least one of the MRI studies. Screening MRI is not currently being
suggested for routine screening of women at average risk, though it is becoming standard
for women who are known to be carriers of BRCA1 or -2 mutations or first degree
relatives of known BRCA1 or -2 carriers, and studies are ongoing in women with a
personal history of breast cancer or other high risk of developing breast cancer.
References:
1. Warner E, Plewes DB, Hill KA, et al. Surveillance of BRCA1 and BRCA2 mutation
carriers with magnetic resonance imaging, ultrasound, mammography, and clinical breast
examination. JAMA 2004; 292: 1317-25.
2. Kriege M, Brekelmans CT, Boetes C, et al. Efficacy of MRI and mammography for
breast-cancer screening in women with a familial or genetic predisposition. N Engl J Med
2004; 351: 427-37.
3. Kuhl CK, Schrading S, Leutner CC, et al. Mammography, breast ultrasound, and
magnetic resonance imaging for surveillance of women at high familial risk for breast
cancer. J Clin Oncol 2005; 23: 8469-76.
4. Leach MO, Boggis CR, Dixon AK, et al. Screening with magnetic resonance imaging
and mammography of a UK population at high familial risk of breast cancer: a
prospective multicentre cohort study (MARIBS). Lancet 2005; 365: 1769-78.
5. Podo F, Sardanelli F, Canese R, et al. The Italian multi-centre project on evaluation of
MRI and other imaging modalities in early detection of breast cancer in subjects at high
genetic risk. J Exp Clin Cancer Res 2002; 21: 115-24.