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Molecular Breast Imaging in Patients With a History of Bloody Nipple Discharge

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00566280
Enrollment
14
Registered
2007-12-03
Start date
2006-10-31
Completion date
2007-12-31
Last updated
2012-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloody Nipple Discharge, Breast Cancer

Keywords

MBI, Mammogram, Breast Cancer, Breast Ultrasound, Bloody Nipple Discharge, Molecular Breast Imaging

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Women age 25 - 75 * Women with a negative diagnostic mammogram and ultrasound * Women with a history of bloody nipple discharge which can not be reproduced by the examining physician or the patient in the office

Exclusion criteria

* Pregnant or lactating * Unable to understand or sign a consent form * Physically unable to sit upright and still for 40 minutes

Design outcomes

Primary

MeasureTime frame
Detection of Breast Cancer6 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026