NCT03405519

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

January 10, 2018

Last Update Submit

August 14, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (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

    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.

    During a radiotherapy planning process, an average of 2 weeks

Study Arms (1)

Radiotherapy planning

OTHER

Radiotherapy planning using both CT and MRI scans

Procedure: Radiotherapy planning using both CT and MRI scans

Interventions

Radiotherapy planning using both CT and MRI scansPROCEDURE

Patients' radiotherapy will be planned using CT and MRI scans in order to establish the best methodology for planning of radiotherapy for nodal disease

Radiotherapy planning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Implanted pacemakers and/or pacing wires
  • Cochlear implants
  • Programmable hydrocephalus shunts
  • Implanted neurostimulation systems
  • Implanted drug infusion pumps
  • Ferromagnetic implants
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Anna Kirby

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 23, 2018

Study Start

December 18, 2017

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

August 17, 2020

Record last verified: 2020-08

Locations

GB(1)