N/A
Completed N=60
The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease
Breast Abnormalities
Source: ClinicalTrials.gov NCT01687790 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. — 27 lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. |
27 | — |
| SECONDARY Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results. |
19 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01687790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.