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
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Oct 2006
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Posted
Study publicly available on registry
December 3, 2007
CompletedJanuary 6, 2012
January 1, 2012
1.2 years
November 30, 2007
January 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of Breast Cancer
6 Months
Study Arms (1)
Molecular Breast Imaging
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating
- Unable to understand or sign a consent form
- Physically unable to sit upright and still for 40 minutes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dietlind L. Wahner-Roedler, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 30, 2007
First Posted
December 3, 2007
Study Start
October 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
January 6, 2012
Record last verified: 2012-01