Clinical trial · Interventional
Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation
NCT00591864CI-TRIAL-00015032MBIcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular Breast Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity on the Per Patient Level
- timeFrame
- within 1 week of surgery or biopsy
- description
- Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.
Secondary outcomes (2)
- measure
- Sensitivity on the Per Tumor Level
- timeFrame
- within 1 week of surgery or biopsy
- description
- Number of tumors detected per number of tumors diagnosed on surgery or biopsy.
- measure
- Specificity
- timeFrame
- at least one year following imaging
- description
- The number of women with negative imaging test per number of women without cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.