The American College of Radiology Imaging Network (ACRIN), with support from the Avon Foundation, has initiated a multicenter clinical trial to evaluate the role of ultrasound as a supplemental screening tool for women with dense breast tissue at high risk for breast cancer. This study is funded by a unique partnership between NCI and the Avon Foundation; data will be collected at 22 institutions across North America with an enrollment goal of approximately 2,800 women.

"Screening Breast Ultrasound for High-Risk Women" (also known as ACRIN 6666) aims to assess the value of integrated whole-breast screening ultrasound combined with mammo-graphy in the detection of breast cancer in high-risk women. Study participants will receive annual mammography and radiologist-performed screening ultrasound, with both tests performed and interpreted independently at study entry and at 12- and 24-month time points.

ACRIN is a national cancer research organization sponsored and funded by the Cancer Imaging Program in NCI's Division of Cancer Treatment and Diagnosis, and includes investigators at more than 100 leading medical facilities across North America and other countries. The Avon Foundation is a nonprofit foundation that supports clinical care, research, and education related to breast cancer. It has provided a grant of more than $4 million to ACRIN to support this initiative. The majority of the grant will go toward funding ACRIN 6666. "Avon's support has allowed us to rapidly move forward with a high-priority research study that addresses an important and emerging issue in breast cancer detection," says ACRIN Network Chair, Dr. Bruce Hillman.

A portion of the grant will support the training of an ACRIN-Avon Fellow in clinical trials of breast imaging. The two-year fellowship will provide training in the development, implementation, and analysis of clinical imaging research.

Dr. Wendie Berg of Baltimore, Md., is the principal investigator for ACRIN 6666. She is leading a multidisciplinary team of breast imagers, statisticians, health outcomes specialists, and ACRIN staff in the development and execution of this trial. "Why isn't ultrasound routinely performed to supplement mammography in women with dense breasts?" says Dr. Berg. "The short answer: In some centers, it already is. The data are compelling, indicating that breast cancer detection will be improved and that the cancers found are usually those with good prognoses."

Funding this trial has been challenging because ACRIN was already committed to two large screening protocols, the Digital Mammographic Screening Trial and the National Lung Screening Trial. Dr. Lawrence Bassett and Dr. Carl D'Orsi brought the protocol to the attention of Ms. Marydale Debor, chief advisor to the Avon Breast Cancer Crusade. After reviewing the scientific rationale for the study, the Avon Foundation awarded the grant to ACRIN, enabling investigators to move forward with trial development.

In addition to the primary goal of evaluating the contribution of supplemental ultrasound, the study will look at the time and resources required to perform screening ultrasound, including induced costs of biopsy and short interval follow-up. Training session modules developed for the study will help ensure consistency among the ultrasound readers. If readers can identify subtle lesions and recognize the vast majority of cancers in the training materials, they should be able to use these techniques with their patients. These training materials will also be widely available to practicing radiologists.

For more information, go to www.acrin.org, Protocol 6666, Screening Breast Ultrasound in High-Risk Women.