Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)

Mayo Clinic

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00890994

08-005522

Details and patient eligibility

About

In this research study, the investigators are testing a new type of breast camera, called Molecular Breast Imaging, to see if it can find tumors in the subject's breast.

Full description

Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study. The investigators plan to recruit 200 patients who are scheduled to undergo a breast biopsy for a breast lesion considered suggestive or highly suggestive of DCIS as determined by a radiologist specializing in breast imaging. Each patient will have a suspicious area of calcification on mammography of extent < 3 cm, or a non-focal area of abnormality on ultrasound or MRI that is scheduled for evaluation by biopsy. Each patient will undergo an MBI study immediately prior to biopsy. The study coordinator will approach these patients and inform them of the research project. If they are interested in participating, informed consent will be obtained and the patient will be scheduled for the MBI study prior to the breast biopsy.

Enrollment: 200 patients

Sex: Female

Ages: 25 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with a breast lesion suspicious for DCIS who are scheduled for a stereotactic breast biopsy.
• Lesion must be considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5).
• Women between 25 and 90 years of age.

Exclusion criteria

• Unable to understand or sign a consent form.
• Pregnant or lactating.
• Physically unable to sit upright and still for 30-40 minutes.

Trial design

200 participants in 1 patient group

Suspected breast cancer