RealMove (Lung): Assessing Tumour Motion With Dynamic MRI (RealMove(lung))

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Tumor
• Intervention / Treatment: Other: Dynamic MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mattias Hedman, MD PhD; Phone Number: +46812370000; Email: mattias.hedman@regionstockholm.se
• Study Contact Backup: Name: Eva Onjukka, PhD; Email: eva.onjukka@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Recruiting
    • Karolinska University Hospital
    • Contact: Eva Onjukka, PhD; Phone Number: +46765696744; Email: eva.onjukka@ki.se
    • Contact: Mattias Hedman, MD/PhD; Phone Number: +46812370000; Email: mattias.hedman@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full cohort; All subjects are included in the same arm.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in amplitude of the tumour motion, as assessed by dynamic MRI and 4D CT, respectively	The two dynamic scans represent the tumour motion through different techniques. If the amplitude indicated by 4D CT is smaller than that indicated by dynamic MRI, the hypothesis is confirmed.	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)	4D CBCT images are acquired at each treatment session, in treatment position. These will assess the stability of the breathing patter through the treatment course.	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	The breathing pattern is represented by a probability density function, indicating the regularity of the motion. The stability of this pattern through the treatment course will be assessed.	Over 3-4 weeks: twice pre-treatment, and three times during treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Review of medical records	Up to 10 years after treatment
Progression-free survival	Review of medical records	Up to 10 years after treatment
Grade ≥2 toxicity assessed by CTCAE v.5.0	Review of medical records	Up to 10 years after treatment
Anxiety during examinations of tumour motion	Measured by a questionnaire	Over 3-4 weeks: twice pre-treatment, and three times during treatment

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Uppsala University Hospital
• Investigators: Principal Investigator: Eva Onjukka, PhD, Karolinska University Hospital/Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): March 17, 2026
• Study Completion (Estimated): March 17, 2036

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Radiotherapy; Dynamic MRI; Motion management
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: K 2023-10103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No