Magnetic Resonance Imaging for Lung Radiotherapy
MRI Lung
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to investigate the use of Magnetic Resonance Imaging (MRI) in the diagnostic and planning phase of radiotherapy for lung cancer and then introduce it into on-treatment imaging to improve the accuracy of radiotherapy. The study compromises of two phases, a technical phase followed by a clinical phase. The aim of the technical phase is to develop and test MR sequences using a diagnostic scanner for use in the chest. This will be carried out on a humanoid phantom and subsequently healthy volunteers. The second phase will be a clinical phase to assess the accuracy of visualising all thoracic structures and the tumour in lung cancer patients using the defined MR sequences. It will compromise of 2 parts; the first part will involve 3 lung cancer patients as a pilot to enable the fine tuning of the sequences. The 2nd part will involve the evaluation of MRI in relation to planning CT in 12 lung cancer patients. The hypothesis is that the use of 4D MRI will be more accurate in defining the tumour and intrathoracic structures thanachieved with the current standard of 4DCT to improve the accuracy and potentially the outcome of radical radiotherapy for non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started May 2018
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2018
CompletedFirst Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedJanuary 5, 2021
February 1, 2020
3.6 years
February 11, 2020
January 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The aim of the technical phase is to develop and test MR sequences using a diagnostic scanner for use in the chest
Measure gross tumour volume (Gross Tumour Volume/ tumour) and normal structures. Two clinical oncologists are generate consensus based tumour motion envelopes on image datasets comprising anatomical planes oriented along each cardinal axis. Dice similarity index (percentage of overlap) and Haussdorf distance (maximum distance between the contours of two structures) are gross tumour volumes s outlined on single phases of 4D-CT and TWIST 4D-MR images, after rigidly registering the centres-of-mass of the two gross tumour volumes.
2 years
Secondary Outcomes (1)
4D MRI will be compared to 4D CT as an imaging methodology
2 years
Study Arms (2)
Study participants cohort I
EXPERIMENTAL3 stage III NSCLC patients receiving radiotherapy will be imaged, each for a single MRI session using TWIST and HASTE sequences.
Study participants cohort II
EXPERIMENTAL12 patients will be imaged, each for two MRI sessions taking place during the radiotherapy schedule and separated by at least a week.
Interventions
Eligibility Criteria
You may qualify if:
- This study will recruit patients due to have radical external beam radiotherapy as per standard institutional practice.
- The criteria specified in the institutional protocol are:
- Histologically verified NSCLC or presumed not histologically verified but MDT reviewed and agreed if obtaining biopsy is considered too risky
- Stage II, IIIA \& IIIB (AJCC, 7th Edition TNM), fully staged with CT, PET-CT +/-EBUS for mediastinal staging
- WHO performance status ≤ 2
- Adequate respiratory function
- Absence of malignant effusion
- Aged 18 and over
You may not qualify if:
- Under 18 years or age
- Patients not able to have radical radiotherapy
- Pregnant or lactating women
- Unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, CH634JY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Brada, PhD, MD
Clatterbridge Cancer Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 19, 2020
Study Start
May 16, 2018
Primary Completion
December 30, 2021
Study Completion
April 30, 2022
Last Updated
January 5, 2021
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share