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Evaluation of Molecular Breast Imaging in Patients With a High Likelihood of Ductal Carcinoma in Situ

25 Years
90 Years
Open (Enrolling by invite only)
Breast Cancer

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Trial Information

Evaluation of Molecular Breast Imaging in Patients With a High Likelihood of Ductal Carcinoma in Situ

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.

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Principal Investigator

Dietlind L. Wahner-Roedler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • MBI
  • Molecular Breast Imaging
  • Breast Cancer
  • DCIS
  • Breast
  • Calcifications
  • Microcalcifications
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal



Mayo Clinic Rochester, Minnesota  55905