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The purpose of this study is to evaluate molecular breast imaging in the workup of patients with a history of bloody nipple discharge, not reproducible in the office who have a negative clinical breast examination, and a negative diagnostic mammogram and breast ultrasound.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Molecular Breast Imaging | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular Breast Imaging | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Breast Cancer | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dietlind L. Wahner-Roedler, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Wahner-Roedler DL, Hruska CB, O'Connor MK, Phillips SW, Whaley DH, Johnson RE, Degnim AC, Boughey JC, Rhodes DJ. Molecular breast imaging for women presenting with a history of non-reproducible bloody nipple discharge and negative findings on routine imaging studies: a pilot study. J Surg Radiol. 2011 Jan 1;2(3):92-9. Epub 2010 Nov 23. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| D017437 |
| Skin and Connective Tissue Diseases |