The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.

University of Pittsburgh1 site in 1 country60 target enrollmentSeptember 2012

ConditionsBreast Abnormalities

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Abnormalities
Sponsor: University of Pittsburgh
Enrollment: 60
Locations: 1
Primary Endpoint: Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary hypothesis of this project is that using molecular breast imaging (MBI) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

September 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Pittsburgh

Responsible Party

Principal Investigator

Christiane Hakim

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

•18 years of age or older
•Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy

Exclusion Criteria

•Known contraindication to mammographic imaging
•women who are pregnant
•women who are lactating
•women who have significant existing breast trauma
•women who have breast implants
•Women under 18 years of age.
•women who had previous benign breast surgery within 1 year
•Males and children
•Women who are unable to understand or execute written informed consent
•Women who refuse to have a biopsy

Outcomes

Primary Outcomes

Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.

Time Frame: 1 year

The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).