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

This study has been completed.
GE Healthcare
Information provided by (Responsible Party):
Christiane Hakim, University of Pittsburgh Identifier:
First received: September 11, 2012
Last updated: December 2, 2014
Last verified: December 2014
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.

Condition Intervention
Breast Abnormalities
Device: molecular breast imaging (Discovery)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • specificity of MBI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • positive predictive value of MBI [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: molecular breast imaging Device: molecular breast imaging (Discovery)
Other Name: Discovery NM750b


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01687790

United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
GE Healthcare
Principal Investigator: Christiane Hakim, MD University of Pittsburgh
  More Information

Responsible Party: Christiane Hakim, Principal Investigator, University of Pittsburgh Identifier: NCT01687790     History of Changes
Other Study ID Numbers: PRO12030005 
Study First Received: September 11, 2012
Last Updated: December 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
molecular breast imaging
breast disease
breast biopsy

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases processed this record on August 29, 2016