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

NCT ID: NCT01687790

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-09-30

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.

Conditions

Breast Abnormalities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

molecular breast imaging

Group Type: EXPERIMENTAL

molecular breast imaging (Discovery)

Intervention Type: DEVICE

Interventions

molecular breast imaging (Discovery)

Intervention Type: DEVICE

Other Intervention Names

Discovery NM750b

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
• Women with any known renal disease - if an MRI is deemed necessary, a serum creatine will be checked prior to injection of contrast. Using the National Kidney Foundation recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive intravenous gadolinium-based MRI contrast. Those individuals with a GFR >30 and <60 can receive the contrast but at a reduced dose (typically half). Those with a GFR <30 will not receive MRI contrast and will not undergo the exam. Breast MRI must be done with contrast if evaluating for cancer. Several factors can affect the GFR such as age, body size, creatinine, renal status and will be calculated from the blood drawn. GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that precludes a Breast MRI with contrast. The final determinant will be the GFR.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Christiane Hakim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christiane Hakim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO12030005

Identifier Type: -

Identifier Source: org_study_id