Molecular Breast Imaging in Patients With a History of Bloody Nipple Discharge
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|ClinicalTrials.gov Identifier: NCT00566280|
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : January 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Bloody Nipple Discharge||Procedure: Molecular Breast Imaging||Not Applicable|
Although the cause of bloody nipple discharge is benign in most cases, the evaluation is focused on excluding a malignant cause. When bloody nipple discharge is clinically reproducible, management traditionally involves surgical duct excision. When bloody nipple discharge is not reproducible and mammogram and ultrasound are negative the management relies on "watchful waiting" - serial breast imaging to exclude a focal finding and continued observation for recurrent bloody nipple discharge. This approach provokes anxiety among patients who do not have a clear explanation for the bloody nipple discharge. Galactography is useful when positive, but has a high false-negative rate. MRI has not been studied in this context and is costly. Ductoscopy may play a diagnostic role in the future, but experience and equipment are limiting variables. The availability of a less costly method of excluding breast cancer would be of great value in this population.
Molecular Breast Imaging (MBI) is a highly promising novel methodology for breast cancer detection developed under the leadership of Dr. Michael O'Connor at Mayo Clinic, Rochester, MN. Preliminary patient studies with our dual-detector system indicate that this system is capable of reliably detecting very small (5-10 mm) malignant lesions in the breast.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
|Molecular Breast Imaging||
Procedure: Molecular Breast Imaging
A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 20 mCi of 99m Tc-sestamibi.
Other Name: MBI
- Detection of Breast Cancer [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566280
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Dietlind L. Wahner-Roedler, M.D.||Mayo Clinic|