Clinical trial · Observational
Magnetic Resonance Breast Tissue Characterisation to Improve Risk Stratification for Breast Cancer
NCT03684733CI-TRIAL-00044011MR-BTCcompletedClinicalTrials.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)
This is a combination retrospective/prospective observational study with two arms:
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Mammography | — | UNRESOLVED | — |
| MRI | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Arm 1: Cohort 1 - Retrospective Analysis
- description
- Participants attending MRI \& XRM for a clinical indication with at least one normal breast
- interventionNames
- Diagnostic Test: MRI
- label
- Arm 2: Cohort 2 - Retrospective Analysis
- description
- BRCA1 or BRCA2 mutation carriers attending MRI \& XRM for breast screening: Genetic risk of breast cancer
- interventionNames
- Diagnostic Test: MRI
- label
- Arm 2: Cohort 3 - Retrospective Analysis
- description
- Participants attending MRI \& XRM for breast screening post mantle radiotherapy: Environmental risk of breast cancer
- interventionNames
- Diagnostic Test: MRI
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 39 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Cohort 1: * Normal breast tissue in one or both breasts * Aged \> 39.5 years * ≤ 6 months between XRM and MRI examinations Cohort 2: * Genetically proven BRCA1 or 2 mutation carrier * Age 39.5 - 50.5 years * ≤ 6 months between XRM and MRI examinations Cohort 3: * Previous mantle radiotherapy * Age 39.5 - 50.5 years * ≤ 6 months between XRM and MRI examinations Cohort 4: * Radiologically healthy breast tissue as assessed by XRM * Age 39.5 - 50.5 years * Able to attend MRI screening within 6 weeks of XRM Exclusion Criteria: Cohort 1: \- Treatment or medication between XRM and MRI examinations Cohort 2: * Previous breast cancer diagnosis and/or treatment * Treatment or medication between XRM and MRI examinations Cohort 3: * Previous breast cancer diagnosis and/or treatment * Treatment or medication between XRM and MRI examinations Cohort 4: * Previous breast cancer diagnosis and/or treatment * MRI incompatible implants * Claustrophobia * Inability to tolerate a 40 minute MRI breast examination * Patients with renal failure or problems with IV access
References
Publications (0)
Data not yet available
No reference posted for this study.