Molecular Breast Imaging in Patients With a History of Bloody Nipple Discharge - Full Text View

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

U.S. FDA Resources

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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Detection of Breast Cancer

Estimated Enrollment:	15
Study Start Date:	November 2007

Detailed Description:

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

Criteria

Inclusion Criteria

Women age 25 or older
Women with a history of BND, which can not be reproduced by the examining physician or the patient in the office with a negative diagnostic mammogram and ultrasound.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566280

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.

Sponsors and Collaborators

Mayo Clinic

Investigators


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
First Received:	November 30, 2007
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00566280
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Bloody Nipple Discharge

Mammogram

Breast Ultrasound

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00566280