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

This study is currently recruiting participants.
Verified September 2012 by University of Pittsburgh
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Christiane Hakim, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01687790
First received: September 11, 2012
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Breast Diseases
U.S. FDA Resources

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 ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: molecular breast imaging Device: molecular breast imaging (Discovery)
Other Name: Discovery NM750b

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 GFR or glomerular filtration rate 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687790

Contacts
Contact: Melissa J Davis, RN 412-623-1053 davismj@upmc.edu

Locations
United States, Pennsylvania
Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Melissa J Davis, RN     412-623-1053     davismj@upmc.edu    
Principal Investigator: Christiane Hakim, MD            
Sponsors and Collaborators
University of Pittsburgh
GE Healthcare
Investigators
Principal Investigator: Christiane Hakim, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Christiane Hakim, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01687790     History of Changes
Other Study ID Numbers: PRO12030005
Study First Received: September 11, 2012
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Congenital Abnormalities
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013