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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890994
• Other study ID #: 08-005522
• Status: Completed
• Phase: N/A
• First received: April 29, 2009
• Last updated: March 21, 2017
• Start date: January 19, 2009
• Est. completion date: November 14, 2016

Study information

• Verified date: March 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 14, 2016
• Est. primary completion date: November 14, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

External Links

•   Mayo Clinic News