RealMove (Lung): Assessing Tumour Motion With Dynamic MRI

Lung Tumor Clinical Trial

— RealMove(lung)  

Official title:

RealMove (Lung): Assessing Tumour Motion With Dynamic MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322329
• Other study ID #: K 2023-10103
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: March 17, 2036

Study information

• Verified date: February 2024
• Source: Region Stockholm
• Contact: Mattias Hedman, MD PhD
• Phone: +46812370000
• Email: mattias.hedman[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 17, 2036
• Est. primary completion date: March 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Lung Tumor

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Evaluated twice pre-treatment, including during the intervention, and three times during treatment
Primary	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.	Evaluated twice pre-treatment, including during the intervention, and three times during treatment
Primary	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.	Evaluated twice pre-treatment, including during the intervention, and three times during treatment
Secondary	Anxiety during examinations of tumour motion	Measured by a questionnaire	Evaluated twice pre-treatment, including during the intervention, and three times during treatment
Secondary	Overall survival	Review of medical records	Up to 10 years after treatment
Secondary	Progression-free survival	Review of medical records	Up to 10 years after treatment
Secondary	Grade =2 toxicity assessed by CTCAE v.5.0	Review of medical records	Up to 10 years after treatment