RealMove (Lung): Assessing Tumour Motion With Dynamic MRI
ConditionLung Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Stockholm
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or breastfeeding, or planned pregnancy or breastfeeding, during treatment
Contraindication for MRI examination
Otherwise incapable of participating in study
Trial design
Design model
Single group
Treatments tested in this trial
Dynamic MRI
Other interventionSubjects 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Full cohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Over 3-4 weeks: twice pre-treatment, and three times during treatment2
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.
Time frame
Over 3-4 weeks: twice pre-treatment, and three times during treatment3
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.
Time frame
Over 3-4 weeks: twice pre-treatment, and three times during treatmentSecondary outcomes
1
Anxiety during examinations of tumour motion
Measured by a questionnaire
Time frame
Over 3-4 weeks: twice pre-treatment, and three times during treatment2
Overall survival
Review of medical records
Time frame
Up to 10 years after treatment3
Progression-free survival
Review of medical records
Time frame
Up to 10 years after treatment4
Grade ≥2 toxicity assessed by CTCAE v.5.0
Review of medical records
Time frame
Up to 10 years after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Stockholm
Lead sponsor
Uppsala University Hospital
Collaborator
Source ClinicalTrials.gov