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

NCT03048760 | Completed

• 1 other identifier: 17_RADIO_121
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

MRI scan; Organs at Risk

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (2)

• Measure differences in inter-patient OAR volumes and intra-patient target and OAR volumes using MRI and CT.

  18 months

• Measure patient experiences of CT and MRI using questionnaires and interviews.

  18 months

Study Arms (1)

MRI scan

EXPERIMENTAL

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

Other: MRI scan

Interventions

MRI scan OTHER

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

MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• University of Manchester: collaborator
• Elekta Limited: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Corinne Faivre-Finn, PhD

  University of Manchester & The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Corinne Favire-Finn

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: February 9, 2017
• Study Start: September 11, 2017
• Primary Completion: January 21, 2019
• Study Completion: January 21, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)