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MR-guided RAdiotherapy to Breast With Dose Escalation to regionaL Lymph NodEs (MIRABELLE)

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ClinicalTrials.gov Identifier: NCT03405519
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Radiotherapy planning using both CT and MRI scans Not Applicable

Detailed Description:
MR imaging has the potential to improve both the localisation of pan-LN treatments and the subsequent treatment delivery using MR-linac technology. The MIRABELLE study will apply the MR sequences developed in LN-negative volunteers/patients to the context of node-positive breast cancer patients with the aim of reducing the delineated nodal volume thereby facilitating dose-escalation to involved LNs. The benefit of using MRI for LN localisation as compared to conventional CT imaging will be investigated by determining whether a higher dose can be delivered using MRI- as compared to CT-based delineation. Any increase in dose will be deemed a success as this has potential to improve tumour control. In addition, inter-observer errors in outlining will be explored to investigate whether these are reduced using MRI. Reduced inter-observer errors would result in smaller margins for error such that less normal tissue could be irradiated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MR-guided RAdiotherapy to Breast With Dose Escalation to regionaL Lymph NodEs
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Radiotherapy planning
Radiotherapy planning using both CT and MRI scans
Procedure: Radiotherapy planning using both CT and MRI scans
Patients' radiotherapy will be planned using CT and MRI scans in order to establish the best methodology for planning of radiotherapy for nodal disease




Primary Outcome Measures :
  1. 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 [ Time Frame: During a radiotherapy planning process, an average of 2 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405519


Contacts
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Contact: Lone Gothard +44 208 661 3460 lone.gothard@icr.ac.uk

Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Helen McNair    +44 208 642 6011    helen.mcnair@rmh.nhs.uk   
Contact: Lone Gothard    +44 208 661 3460    lone.gothard@icr.ac.uk   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
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Principal Investigator: Anna Kirby Royal Marsden NHS Foundation Trust

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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03405519     History of Changes
Other Study ID Numbers: CCR4738
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No