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

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ClinicalTrials.gov Identifier: NCT01687790
Recruitment Status : Completed
First Posted : September 19, 2012
Results First Posted : September 20, 2016
Last Update Posted : September 20, 2016
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Christiane Hakim, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Breast Abnormalities Device: molecular breast imaging (Discovery) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: molecular breast imaging Device: molecular breast imaging (Discovery)
Other Name: Discovery NM750b



Primary Outcome Measures :
  1. Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. [ Time Frame: 1 year ]
    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).


Secondary Outcome Measures :
  1. Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results. [ Time Frame: 1 year ]
    Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687790


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

Responsible Party: Christiane Hakim, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01687790     History of Changes
Other Study ID Numbers: PRO12030005
First Posted: September 19, 2012    Key Record Dates
Results First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Breast Diseases
Skin Diseases