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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


N/A
25 Years
75 Years
Not Enrolling
Female
Breast Cancer, Bloody Nipple Discharge

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Detection of Breast Cancer

Outcome Time Frame:

6 Months

Safety Issue:

Yes

Principal Investigator

Dietlind L. Wahner-Roedler, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

06-003072

NCT ID:

NCT00566280

Start Date:

October 2006

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Bloody Nipple Discharge
  • MBI
  • Mammogram
  • Breast Cancer
  • Breast Ultrasound
  • Bloody Nipple Discharge
  • Molecular Breast Imaging
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905