Clinical trial NCT03048760: Magnetic Resonance Imaging (MRI) for the Delineation of Organs At Risk (OAR) and Target Volumes in Lung Cancer Patients
Official title: Magnetic Resonance Imaging (MRI) for the Delineation of Organs At Risk (OAR) and Target Volumes in Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: MRI scan
Organs at Risk
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Elekta Limited
First posted: 2017-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Measure differences between target and OAR volumes contoured on PET, CT and MRI images.
timeFrame: 18 months
Secondary outcomes:
measure: Measure differences in inter-patient OAR volumes and intra-patient target and OAR volumes using MRI and CT.
timeFrame: 18 months
measure: Measure patient experiences of CT and MRI using questionnaires and interviews.
timeFrame: 18 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: University of Manchester & The Christie NHS Foundation Trust
name: Corinne Faivre-Finn, PhD
role: PRINCIPAL_INVESTIGATOR
References: