Clinical trial · Interventional
Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer
NCT02590458CI-TRIAL-00048579completedEarly Phase 1ClinicalTrials.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 goal of this clinical research study is to test if a short breast MRI scan (about 10 minutes) can be used for breast cancer screening in high risk people and to learn if it is as effective as a routine breast MRI scan (30-60 minutes).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
| Short Breast MRI (SBMRI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Short Breast MRI (SBMRI)
- description
- Routine scheduled MRI with contrast performed on women at high risk of developing breast cancer. One day after routine MRI, short breast MRI (SBMRI) with contrast performed. After SBMRI, participant completes a questionnaire about their comfort level and experience of the research scan.
- interventionNames
- Procedure: Short Breast MRI (SBMRI)
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants
- timeFrame
- 1 day
- description
- Radiologists blinded to patient outcome review images from each study independently and rate the possibility of breast cancer using BI-RADS score. BIRADS 0, 3,4, 5 considered positive, BIRADS 1 and 2 considered negative results for the analysis. Each reader's score for a given case assessed both independently and on a separate session, as consensus.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years and older female patients 2. BMRI indication: high risk screening per ACS guidelines 3. No contraindications to undergo MRI 4. Creatinine \</=1.3 and GFR\> 40 5. No requirement for sedation. Exclusion Criteria: 1. \<18 years 2. Male 3. Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother 4. Contraindication to Gd contrast agents 5. Previous documented history of moderate to severe hypersensitivity to Gd contrast agents 6. Contraindications to MRI
References
Publications (0)
Data not yet available
No reference posted for this study.