Clinical trial · Interventional
MR-guided RAdiotherapy to Breast With Dose Escalation to regionaL Lymph NodEs
- 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)
Radiotherapy to the breast and lymph nodes is routinely planned using CT scans. The introduction of magnetic resonance imaging (MRI) has the potential to better visualise the lymph nodes and so define a smaller treatment area or 'target'. This means that the dose delivered to the target could be increased without increasing the dose to normal tissues. The MIRABELLE study is designed to test if this is possible by recruiting patients diagnosed with breast cancer including lymph node disease. The investigators will ask participants to have a CT scan and an MRI scan before they have radiotherapy. The investigators will then plan radiotherapy using both these scans and compare the possible dose delivered to the lymph nodes using the MRI and CT defined lymph nodes. This will not affect the patient's future treatment.
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 |
|---|---|---|---|
| Radiotherapy planning using both CT and MRI scans | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Radiotherapy planning
- description
- Radiotherapy planning using both CT and MRI scans
- interventionNames
- Procedure: Radiotherapy planning using both CT and MRI scans
Primary outcomes (1)
- measure
- The number of patients in whom a higher dose can be delivered to the level IV (SCF) nodes without breaching brachial plexus constraints on the radiotherapy plans created using MR images compared with CT images
- timeFrame
- During a radiotherapy planning process, an average of 2 weeks
- description
- MR images are acquired with patient in a position as close as possible to the radiotherapy CT planning position. Images are acquired in a radiotherapy CT scanner with patient in a position replicating that achieved in the MRI scanner. The images are imported into a treatment planning system and consensus lymph node volume agreed between an expert radiation oncologist and MR radiologist. All pan-LN will be delineated on co-registered MRI sequences and on CT (using ESTRO guidelines) by 7 observers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Female or male * Invasive carcinoma of the breast (left or right-sided) * cT1-T4,N3,M0-1 disease * Due to proceed to primary treatment (chemo, surgery, radiotherapy and/or endocrine therapy) * Histopathological involvement of axillary lymph nodes confirmed on FNA or Bx * Likely to undergo locoregional radiotherapy as part of their breast cancer management Exclusion Criteria: * Implanted pacemakers and/or pacing wires * Cochlear implants * Programmable hydrocephalus shunts * Implanted neurostimulation systems * Implanted drug infusion pumps * Ferromagnetic implants * Claustrophobia
References
Publications (0)
Data not yet available