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

Breast Cancer Clinical Trial

— MIRABELLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405519
• Other study ID #: CCR4738
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: December 12, 2019

Study information

• Verified date: August 2020
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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