N/A
N=89
Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00591864 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Sensitivity on the Per Patient Level — 25; 27 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Molecular Breast Imaging (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity on the Per Patient Level |
25; 27 | — |
| SECONDARY Sensitivity on the Per Tumor Level |
32; 36 | — |
| SECONDARY Specificity |
38; 37 | — |
Summary
The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.
Eligibility Criteria
Inclusion Criteria
- This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER.
- Patients must not be lactating or pregnant.
- All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study.
- women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer).
Exclusion Criteria
- They are unable to understand and sign the consent form
- They are pregnant or lactating
- They are physically unable to sit upright and still for 40 minutes.
- The breast MRI is for screening purposes or to determine the status of breast augmentation.
- They have undergone breast surgery within the previous year
Data sourced from ClinicalTrials.gov (NCT00591864). 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.