Clinical trial NCT00566280: Molecular Breast Imaging in Patients With a History of Bloody Nipple Discharge
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Bloody Nipple Discharge
Keywords: MBI
Mammogram
Breast Cancer
Breast Ultrasound
Bloody Nipple Discharge
Molecular Breast Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2007-12-03
Enrollment: 14
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of Breast Cancer
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dietlind L. Wahner-Roedler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.