Dear Referring Physician

[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.