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| Sponsored by: |
Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00566280 |
Purpose
The purpose of this study is to evaluate molecular breast imaging in patients who present with a history of bloody nipple discharge, which can not be reproduced in the doctor's office and have a normal mammogram and ultrasound of the breast.
| Condition | Intervention |
|---|---|
|
Bloody Nipple Discharge |
Procedure: Molecular Breast Imaging |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Molecular Breast Imaging: Evaluation of a New Technique Using Scintimammography as an Additional Diagnostic Tool for Women Presenting With a History of Bloody Nipple Discharge and Negative Routine Imaging Studies - a Pilot Study |
| Estimated Enrollment: | 15 |
| Study Start Date: | November 2007 |
We plan to recruit 15 patients presenting to the breast clinic for evaluation of BND, in whom BND can not be reproduced by the examining physician or the patient while in the office. Patients will undergo diagnostic mammogram and ultrasound, and if these imaging procedures are negative, will be offered participation in the MBI-BND study. 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. If indicated a pregnancy test will be obtained prior to the MBI.
If MBI is read as negative (-) or benign (+), the patient will be asked to return for a repeat mammogram, ultrasound and MBI in 6 months or earlier if the BND should recur.
If the MBI is positive (++ to ++++) additional studies will be performed. These may include some or all of the following: special mammographic views, focused breast ultrasound, contrast enhanced breast MRI, image guided biopsy, follow-up mammogram, ultrasound and MBI at 6 months (see flow chart).
The patient will be advised to return at any time if the BND recurs or if the patient notices any breast changes of concern. If reproducible BND occurs the patient will be seen in surgical consultation for consideration of duct excision.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States | |
| Contact: Barbara K Siem 507-266-2997 siem.barb@mayo.edu | |
| Principal Investigator: Dietlind L. Wahner-Roedler, M.D. | |
| Principal Investigator: | Dietlind L. Wahner-Roedler, M.D. | Mayo Clinic |
More Information
| Responsible Party: | Mayo Clinic ( Dietlind L. Wahner-Roedler, M.D. ) |
| Study ID Numbers: | 06-003072 |
| Study First Received: | November 30, 2007 |
| Last Updated: | November 30, 2007 |
| ClinicalTrials.gov Identifier: | NCT00566280 |
| Health Authority: | United States: Institutional Review Board |
|
Bloody Nipple Discharge Mammogram Breast Ultrasound |
