Lung TumorRealMove(lung)NCT06322329
RealMove (Lung): Assessing Tumour Motion With Dynamic MRI
A study testing Dynamic MRI in people with Lung Tumor, run by Region Stockholm at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Tumor
- What is being tested?
- Dynamic MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2024to 17 Mar 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or breastfeeding, or planned pregnancy or breastfeeding, during treatment
- Contraindication for MRI examination
- Otherwise incapable of participating in study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eva Onjukka, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Eva Onjukka, PhD, +46765696744, eva.onjukka@ki.se
Mattias Hedman, MD/PhD, +46812370000, mattias.hedman@regionstockholm.se
About this study
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.
Read the 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.
- Conditions
- Lung Tumor
- Being tested
- Dynamic MRI
- Keywords
- Radiotherapy, Motion management, Dynamic MRI
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Full cohort | Experimental | All subjects are included in the same arm. Receives: Other: Dynamic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Over 3-4 weeks: twice pre-treatment, and three times during treatment
Secondary outcomes (4)
Anxiety during examinations of tumour motion
Measured by a questionnaire
Measured: Over 3-4 weeks: twice pre-treatment, and three times during treatment
Overall survival
Review of medical records
Measured: Up to 10 years after treatment
Progression-free survival
Review of medical records
Measured: Up to 10 years after treatment
Grade ≥2 toxicity assessed by CTCAE v.5.0
Review of medical records
Measured: Up to 10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start15 Mar 2024
- Primary completion17 Mar 2026 (estimated)
- Study completion17 Mar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TumorStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Eva Onjukka, PhD, Principal investigator, Karolinska University Hospital/Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322329
- Sponsor's protocol ID
- K 2023-10103
- Acronym
- RealMove(lung)
- Status last verified
- Apr 2025
- First submitted
- 8 Mar 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RealMove (Lung): Assessing Tumour Motion With Dynamic MRI
- ClinicalTrials.gov ID
- NCT06322329
- Acronym / sponsor ID
- RealMove(lung) / K 2023-10103
- Conditions
- Lung Tumor
- Keywords
- Radiotherapy, Motion management, Dynamic MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Uppsala University Hospital
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 17 Mar 2026 (estimated)
- Study completion
- 17 Mar 2036 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full cohort | Experimental | Other: Dynamic MRIAll subjects are included in the same arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding, or planned pregnancy or breastfeeding, during treatment
- Contraindication for MRI examination
- Otherwise incapable of participating in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic MRISubjects 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. | Other | Full cohort |
Primary outcome
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.
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.
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.
4 secondary outcomes
Anxiety during examinations of tumour motion
Time frame: Over 3-4 weeks: twice pre-treatment, and three times during treatment
Overall survival
Time frame: Up to 10 years after treatment
Progression-free survival
Time frame: Up to 10 years after treatment
Grade ≥2 toxicity assessed by CTCAE v.5.0
Time frame: Up to 10 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
Related trials for Lung Tumor
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Onjukka, PhD contact
Eva Onjukka, PhD principal investigator
Karolinska University Hospital/Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic MRI in people with Lung Tumor, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattias Hedman, MD PhD (+46812370000, mattias.hedman@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.