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Trial Title:
RealMove (Lung): Assessing Tumour Motion With Dynamic MRI
NCT ID:
NCT06322329
Condition:
Lung Tumor
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Radiotherapy
Motion management
Dynamic MRI
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Dynamic MRI
Description:
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.
Arm group label:
Full cohort
Summary:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
17176
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Eva Onjukka, PhD
Phone:
+46765696744
Email:
eva.onjukka@ki.se
Contact backup:
Last name:
Mattias Hedman, MD/PhD
Phone:
+46812370000
Email:
mattias.hedman@regionstockholm.se
Start date:
March 15, 2024
Completion date:
March 17, 2036
Lead sponsor:
Agency:
Region Stockholm
Agency class:
Other
Collaborator:
Agency:
Uppsala University Hospital
Agency class:
Other
Source:
Region Stockholm
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06322329