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

Breast Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687790
• Other study ID #: PRO12030005
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: December 2, 2014
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Abnormalities
• Breast Diseases

Intervention

Device:
• molecular breast imaging (Discovery)

Locations

Country	Name	City	State
United States	Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	specificity of MBI	We will compare the outcome of the biopsies with the determinations made with the MBI examinations. The rate of unnecessary biopsies will be determined by the specificity and prevalence of cancer in the dataset. Thus, we formulate our primary statistical hypothesis in terms of a reduction in the false positive frequency (namely an improvement in specificity) of the pre-biopsy diagnostic work-up that includes MBI.	1 year	No
Secondary	positive predictive value of MBI		1 year	No