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NCT Number: NCT06322329

RealMove (Lung): Assessing Tumour Motion With Dynamic MRI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic MRI

Other

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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

Secondary outcomes

  1. Anxiety during examinations of tumour motion

    Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment

    Measured by a questionnaire

  2. Overall survival

    Time frame: Up to 10 years after treatment

    Review of medical records

  3. Progression-free survival

    Time frame: Up to 10 years after treatment

    Review of medical records

  4. Grade ≥2 toxicity assessed by CTCAE v.5.0

    Time frame: Up to 10 years after treatment

    Review of medical records

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Onjukka, PhD

CONTACT

[email protected]

Mattias Hedman, MD PhD

CONTACT

[email protected]

+46812370000

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Uppsala University Hospital

Registry information

Acronym: RealMove(lung)

Important dates

Study start
2024
Primary completion
2026
Study completion
2036
First posted
Mar 21, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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