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Magnetic Resonance Imaging (MRI) for the Delineation of Organs At Risk (OAR) and Target Volumes in Lung Cancer Patients (MR-Lung)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MRI scan
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lung Cancer focused on measuring MRI scan, Organs at Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stage I-III Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) (histological diagnosis not mandatory)
  • Tumour Characteristics:

    • Size ≥ 3 cm in diameter
    • Positions: range of tumour positions with at least 10 of the participants having lower lobe tumours
  • Patients planned for radical radiotherapy
  • Eastern Co-operative Oncology Group (ECOG) Performance Status (PS) 0-2

Exclusion Criteria:

  • Any contraindications to MR identified after MR safety screening including completion of an MR Safety Screening Form
  • Unable to lie supine for 60 minutes
  • Pregnancy

Sites / Locations

  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI scan

Arm Description

All participants will undergo 2 MRI scans - 1 at the time of their radiotherapy planning scan & 1 after approx. 2 weeks of radiotherapy treatment.

Outcomes

Primary Outcome Measures

Measure differences between target and OAR volumes contoured on PET, CT and MRI images.

Secondary Outcome Measures

Measure differences in inter-patient OAR volumes and intra-patient target and OAR volumes using MRI and CT.
Measure patient experiences of CT and MRI using questionnaires and interviews.

Full Information

First Posted
January 16, 2017
Last Updated
July 4, 2019
Sponsor
The Christie NHS Foundation Trust
Collaborators
University of Manchester, Elekta Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03048760
Brief Title
Magnetic Resonance Imaging (MRI) for the Delineation of Organs At Risk (OAR) and Target Volumes in Lung Cancer Patients
Acronym
MR-Lung
Official Title
Magnetic Resonance Imaging (MRI) for the Delineation of Organs At Risk (OAR) and Target Volumes in Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2017 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
January 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Christie NHS Foundation Trust
Collaborators
University of Manchester, Elekta Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The Christie NHS Foundation Trust is one of seven sites worldwide within the Atlantic consortium that is developing the Elekta MR-Linac (MRL) prior to commercial release at the end of 2017. The MRL allows MR images of patients to be acquired before, during and following radiotherapy (RT). One area where The Christie is taking the lead within the consortium is the application of the MRL for lung imaging and treatment, an area where MRI has hardly been used. MRI scans provide greater soft tissue contrast than CT scans which can aid in the accurate delineation of organs at risk (OAR) and tumour target volumes for MRL and routine treatment. In addition, MRI can provide real time imaging which can aid in the accurate motion characterisation of these volumes. The addition of functional diffusion weighted imaging (DWI) has also proven to be useful in the discrimination of malignant from benign lesions; for lymph node detection and for the differentiation of tumour from atelectasis. Auto-contouring has the potential to speed workflows at various points in the clinical pathway. This may be inter-patient contour propagation used pre-treatment for plan creation, or may be during online or offline adaptive workflows propagating contours through imaging acquired as treatment progresses. In collaboration with industry the investigators will be testing such algorithms on these images retrospectively. In addition, the investigators would also like to evaluate patients' experiences of CT and MRI scans and determine which scanning method is preferred. Other studies have explored patient experiences of MRI compared to CT but not in the lung cancer patient population.
Detailed Description
Participants on this study will have two MRI scans in addition to the CT treatment planning scan, which is standard of care and cone beam CT scans during treatment, which are also standard of care. One of the MR scans will be close to the start of treatment and the other will be approximately 2 weeks after the start of radiotherapy treatment. If the patient has had a PET scan within 4 weeks of the 1st MR scan then the PET images will also be used for target volume delineation. If the PET scan > 4 weeks old, it can be repeated as per standard practice. The MRI protocol includes up to 60 minutes of scanning which will include anatomical, respiratory dynamic and functional diffusion weighted imaging (DWI). The patient will be set up according to the treatment position on the MR scanner, using flat couch. The MR scans will not be used for clinical decision making. Clinicians will then contour organs at risk (OARs) and target volumes on both the CT (guided by PET if available) and MRI scans and contours will be compared to determine the usefulness of MRI for radiotherapy treatment planning. The contoured data sets will be fully anonymised, and used in house and shared with Elekta to assist with the development of automatic contouring / tumour tracking software, comparing CT to cone beam CT (CBCT) tracking (standard of care) with MR to MR tracking (experimental). To assess experiences of MRI and CT, participants will be asked to complete baseline self-report questionnaires and additional questionnaires after MRI and CT scans. A small sample of participants will also be invited to participate in a semi-structured interview to explore their experiences in greater depth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
MRI scan, Organs at Risk

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI scan
Arm Type
Experimental
Arm Description
All participants will undergo 2 MRI scans - 1 at the time of their radiotherapy planning scan & 1 after approx. 2 weeks of radiotherapy treatment.
Intervention Type
Other
Intervention Name(s)
MRI scan
Intervention Description
All participants will undergo 2 MRI scans - 1 at the time of their radiotherapy planning scans & 1 after approx. 2 weeks of radiotherapy treatment.
Primary Outcome Measure Information:
Title
Measure differences between target and OAR volumes contoured on PET, CT and MRI images.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Measure differences in inter-patient OAR volumes and intra-patient target and OAR volumes using MRI and CT.
Time Frame
18 months
Title
Measure patient experiences of CT and MRI using questionnaires and interviews.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stage I-III Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) (histological diagnosis not mandatory) Tumour Characteristics: Size ≥ 3 cm in diameter Positions: range of tumour positions with at least 10 of the participants having lower lobe tumours Patients planned for radical radiotherapy Eastern Co-operative Oncology Group (ECOG) Performance Status (PS) 0-2 Exclusion Criteria: Any contraindications to MR identified after MR safety screening including completion of an MR Safety Screening Form Unable to lie supine for 60 minutes Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Faivre-Finn, PhD
Organizational Affiliation
University of Manchester & The Christie NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The contoured data sets will be fully anonymised, and used in house and shared with Elekta to assist with the development of automatic contouring / tumour tracking software, comparing CT to cone beam CT (CBCT) tracking (standard of care) with MR to MR tracking (experimental).

Learn more about this trial

Magnetic Resonance Imaging (MRI) for the Delineation of Organs At Risk (OAR) and Target Volumes in Lung Cancer Patients

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