Trial record 13 of 1721 for:
Open Studies | "Breast Diseases"
The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease
Verified September 2013 by University of Pittsburgh
Information provided by (Responsible Party):
Christiane Hakim, University of Pittsburgh
First received: September 11, 2012
Last updated: September 30, 2013
Last verified: September 2013
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.
Device: molecular breast imaging (Discovery)
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
Experimental: molecular breast imaging
Device: molecular breast imaging (Discovery)
Other Name: Discovery NM750b
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 18 years of age or older
- Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy
- 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 ClinicalTrials.gov identifier: NCT01687790
|Hillman Cancer Center
|Pittsburgh, Pennsylvania, United States, 15232 |
|Contact: Melissa J Davis, RN 412-623-1053 firstname.lastname@example.org |
|Principal Investigator: Christiane Hakim, MD |
University of Pittsburgh
||Christiane Hakim, MD
||University of Pittsburgh
No publications provided
||Christiane Hakim, Principal Investigator, University of Pittsburgh
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 11, 2012
||September 30, 2013
||United States: Institutional Review Board
Keywords provided by University of Pittsburgh:
molecular breast imaging
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2014