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

NCT01687790 | Completed Results

• 1 other identifier: PRO12030005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

molecular breast imaging; breast disease; breast biopsy

Outcome Measures

Primary Outcomes (1)

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

  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).

  1 year

Secondary Outcomes (1)

• Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.

  1 year

Study Arms (1)

molecular breast imaging

EXPERIMENTAL

Device: molecular breast imaging (Discovery)

Interventions

molecular breast imaging (Discovery) DEVICE

Also known as: Discovery NM750b

molecular breast imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• GE Healthcare: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Christiane Hakim
• Organization: University of Pittsburgh

chakim@magee.edu

412-641-1965

Study Officials

• Christiane Hakim, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: September 11, 2012
• First Posted: September 19, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 20, 2016
• Results First Posted: September 20, 2016

Record last verified: 2016-07

Locations

US (1)