RealMove (Lung): Assessing Tumour Motion With Dynamic MRI

Overview

The study aims to develop an improved method to tailor the geometric safety margin when treating with stereotactic body radiotherapy (SBRT), to avoid tumour cells being missed during irradiation and to limit the exposure of normal tissues as much as possible. Dynamic magnetic resonance imaging (MRI) is assumed to represent the tumour motion during the respiratory cycle more realistically, compared to 4-dimensional computed tomography (4D CT), thanks to its high temporal resolution and the possibility to image the motion over a longer period of time. Patients receiving SBRT for a pulmonary target located below the level of the carina are included in the study, and the hypothesis will be tested through a comparison of the tumour amplitude measured with each modality. Furthermore, the predictive value of the image series acquired at treatment planning, for the motion patterns observed at each treatment fraction, will be evaluated through repeated 4D CBCT acquisitions.

Detailed description

In the current study, a 2D-cine MRI examination will be performed, in addition to the 4D CT examination that is standard for patients receiving radiotherapy for tumours in the thorax or abdomen. A subgroup of the study participants (referred to as the 4D CBCT subcohort) will also be required to perform a 4D CBCT examination at three treatment sessions. The main cohort consists of 95 subjects and the 4D CBCT subcohort of 55 subjects. The study does not involve any change in the treatment routine; rather, the study images are collected for retrospective analysis. Following each imaging session, the subject should fill out an anxiety questionnaire and their pulse will be measured, to give an indication of any anxiety which might influence the breathing pattern of the current session.

Clinical follow-up will be performed retrospectively by reviewing the participants' medical records. Progress, health status and treatment-related toxicity will be evaluated, up to 10 years after completed treatment.

The study objectives are:

* To evaluate dynamic MRI for characterising the respiratory-related tumour motion, compared to the current standard modality of 4D CT. * To evaluate the variation in breathing motion at different times points. * To evaluate the clinical outcome.

Interventions

• Other Dynamic MRI
  Subjects receive a study-specific dynamic MRI scan. If the hypothesis of the study is confirmed, this examination can be used to inform future patients' treatment planning, replacing the use of 4D CT.

Primary outcome measures

• Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively [Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment]
• Difference in amplitude of the tumour motion, assessed at different times (using dynamic MRI and 4D CBCT) [Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment]
• Difference in the structure of the probability density function, assessed at different times [Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment]

Secondary outcome measures (4)

• Anxiety during examinations of tumour motion [Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment]
• Overall survival [Time frame: Up to 10 years after treatment]
• Progression-free survival [Time frame: Up to 10 years after treatment]
• Grade ≥2 toxicity assessed by CTCAE v.5.0 [Time frame: Up to 10 years after treatment]

Eligibility criteria

Inclusion criteria

• Accepted for SBRT treatment of one or more caudally situated lung targets (NSCLC or metastases), i.e. below the carina.
• Age ≥ 18 years
• Adequate clinical condition to maintain immobilised position for at least 30 minutes
• Adequate Swedish skills and cognitive function to understand study information and to fill in the questionnaire

Exclusion criteria

• Pregnancy or breastfeeding, or planned pregnancy or breastfeeding, during treatment
• Contraindication for MRI examination
• Otherwise incapable of participating in study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Karolinska University Hospital — Stockholm

Identifiers

NCT: NCT06322329 · K 2023-10103

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗