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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00566280
First received: November 30, 2007
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Bloody Nipple Discharge
Procedure: Molecular Breast Imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Detection of Breast Cancer [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: October 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00566280

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dietlind L. Wahner-Roedler, M.D. Mayo Clinic
  More Information

Publications:
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.

Responsible Party: Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00566280     History of Changes
Other Study ID Numbers: 06-003072
Study First Received: November 30, 2007
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
MBI
Mammogram
Breast Cancer
Breast Ultrasound
Bloody Nipple Discharge
Molecular Breast Imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014