Cancer of LungREMINDNCT05844761
Real-time Motion Management During Prostate and Lung Radiotherapy
A study testing Triggered imaging on TrueBeam with margin reduction, Synchrony MLC tracking on fiducials with margin reduction and Synchrony MLC tracking and lung adaptive model with margin reduction in people with Cancer of Lung and Lung Metastasis, run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this interventional non-inferiority trial is to assess the accuracy of different real-time motion management radiotherapy techniques. The main question the study aims to answer are: What are the target margins for radiotherapy with motion management that are not inferior to target margin without motion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Lung, Lung Metastasis, Cancer of Prostate
- What is being tested?
- Triggered imaging on TrueBeam with margin reduction, Synchrony MLC tracking on fiducials with margin reduction and Synchrony MLC tracking and lung adaptive model with margin reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2023to Dec 2027
- 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
- For prostate cancer patients:
- Patients histologically proven prostate adenocarcinoma
- Prostate specific antigen (PSA) obtained within three months prior to enrollment
- Localised prostate cancer at any stage eligible for radiotherapy: i.e. any T- or Gleason stage, but no pelvic lymph nodes can be included within the target to be treated
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Ability to understand and the willingness to sign a written informed consent document.
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- Hypofractionated radiation therapy (HYPO) fractionated patients with a prescribed dose of 42.7Gy in 7 fractions.
- MRIOnly workflow meaning synthetic generated CT based on Magnetic resonance imaging (MRI)
- Patients over 40 years old
- For lung cancer patients:
- Lung cancer or localised metastatic disease from other cancer diagnoses, accepted for stereotactic radiotherapy to 45Gy in 3 fractions
- Lesion distinguishable on Computer Tomography and where the majority of adjacent tissue is the lung.
- Ability to understand and the willingness to sign a written informed consent document.
- Is able to perform treatment simulation
Who cannot join
- For prostate cancer patients:
- Patient must have three gold fiducial markers inserted in the prostate
- Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
- Patients with overlapping implanted gold fiducials in X-ray imaging
- Unfeasible to track fiducials with kv imaging/existing online imaging systems
- For lung cancer patients:
- Previous treatment with radiotherapy for lung cancer or lung metastasis
- Idiopathic lung fibrosis
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this interventional non-inferiority trial is to assess the accuracy of different real-time motion management radiotherapy techniques. The main question the study aims to answer are:
- What are the target margins for radiotherapy with motion management that are not inferior to target margin without motion management
- What are the dosimetric and geometrical accuracy to patient for the motion management techniques.
Participants will answer QoL questionary, and the accuracy of treatment will be assessed from treatment data.
Read the detailed description
This study will assess the feasibility of implementing real-time tracking in a clinical setting to account for the relative motion of the moving tumours localised to the prostate or lung. The capability to track the treatment target's motion will ensure that the dose prescribed by the radiation oncologist is the dose delivered to the target and minimises side effects to the critical organs.
During radiation treatment, the target position will be monitored in real-time using built-in imaging technology. The radiation beam shape will be altered to compensate for the moved target positions by the treatment delivery system. The delivered dose to the patient will be calculated after the treatment and compared to the dose without real-time tracking to assess the potential benefit to treatment efficacy, recognising that the radiation dose received by tumour tissue is a very strong biomarker for response.
The estimated dose distributions will be compared to the original plan for non-inferiority using the dose reconstruction method based on the prostate motion trajectory and the logged MLC positions (beam shapes).
Also, the impact on organs at risk doses due to MLC target tracking.
- Conditions
- Cancer of Lung, Lung Metastasis, Cancer of Prostate
- Being tested
- Triggered imaging on TrueBeam with margin reduction, Synchrony MLC tracking on fiducials with margin reduction, Synchrony MLC tracking and lung adaptive model with margin reduction
- Medical subject headings
- Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triggered imaging on TrueBeam with margin reductionRadiation
At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique.
Synchrony MLC tracking on fiducials with margin reductionRadiation
At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique.
Synchrony MLC tracking and lung adaptive model with margin reductionRadiation
At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique for lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Triggered Imaging with TrueBeam for prostate cancer | Experimental | Patients will undergo radiotherapy using the Triggered Imaging technique with TrueBeam for prostate cancer. The technology on the TrueBeam allows for monitoring and gating of the radiation beam in relation to the target position. Receives: Radiation: Triggered imaging on TrueBeam with margin reduction |
| Synchrony with Radixact for prostate cancer | Experimental | Patients will undergo radiotherapy using the Synchrony technique with Radixact for prostate cancer. Multi-Leaf Collimator Adaptation (MLC) and kilovoltage (kV) Intrafraction Monitoring with the Synchrony technique on the Radixact radiotherapy machine. Receives: Radiation: Synchrony MLC tracking on fiducials with margin reduction |
| Synchrony with Radixact for lung cancer | Experimental | Patients will undergo radiotherapy using the Synchrony technique with Radixact for lung cancer. MLC Adaptation, Respiratory Motion Tracking, and kV Intrafraction Monitoring with the adaptive Synchrony technique on the Radixact radiotherapy machine. Receives: Radiation: Synchrony MLC tracking and lung adaptive model with margin reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosemetric accuracy
Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.
Measured: At treatment completion, approximately 1-4 weeks
Secondary outcomes (4)
Geometric accuracy
The geometric accuracy of the beam shape, determined by comparing the ideal beam shape with the actual beam shape based on the centroid of the shape as assessed with mean absolute error (MAE)
Measured: At treatment completion, approximately 1-4 weeks
Motion trajectory
Motion trajectory measured by kilovoltage imaging, including any prediction algorithms compared to without latency and other limitations compared with MAE.
Measured: At treatment completion, approximately 1-4 weeks
Acute Toxicity
EORTC guided and physician assessed
Measured: Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction..
Mechanical & software failure
The percentage of fractions delivered without software or mechanical failure
Measured: At treatment completion, approximately 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LungStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will undergo radiotherapy using motion management techniques: Triggered Imaging with TrueBeam for prostate cancer, Synchrony with Radixact for prostate cancer, and Synchrony with Radixact for lung cancer. Dosimetric coverage will be assessed after treatment based on the accuracy of the motion management techniques and compared with dose coverage without motion management. After interim analysis, Planning target volume (PTV) will be reduced based on dosimetric accuracy in each arm.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Änghede Haraldsson, Region Skane
- Investigators
- André Haraldsson, PhD, MPE, Principal investigator, Skane university hospital, Lund university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844761
- Sponsor's protocol ID
- 2022-05273-01
- Acronym
- REMIND
- Status last verified
- Jul 2026
- First submitted
- 11 Apr 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data used in this study contains sensitive information about the study participants and they did not provide consent for public data sharing. The current approval by the Swedish Ethical Review Authority does not include data sharing. A minimal data set could be shared by request from a qualified academic investigator for the sole purpose of replicating the present study, provided the data transfer is in agreement with European Union legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Motion Management During Prostate and Lung Radiotherapy
- ClinicalTrials.gov ID
- NCT05844761
- Acronym / sponsor ID
- REMIND / 2022-05273-01
- Conditions
- Cancer of Lung, Lung Metastasis, Cancer of Prostate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2023 (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 goal of this interventional non-inferiority trial is to assess the accuracy of different real-time motion management radiotherapy techniques. The main question the study aims to answer are:
- What are the target margins for radiotherapy with motion management that are not inferior to target margin without motion management
- What are the dosimetric and geometrical accuracy to patient for the motion management techniques.
Participants will answer QoL questionary, and the accuracy of treatment will be assessed from treatment data.
Detailed description
This study will assess the feasibility of implementing real-time tracking in a clinical setting to account for the relative motion of the moving tumours localised to the prostate or lung. The capability to track the treatment target's motion will ensure that the dose prescribed by the radiation oncologist is the dose delivered to the target and minimises side effects to the critical organs.
During radiation treatment, the target position will be monitored in real-time using built-in imaging technology. The radiation beam shape will be altered to compensate for the moved target positions by the treatment delivery system. The delivered dose to the patient will be calculated after the treatment and compared to the dose without real-time tracking to assess the potential benefit to treatment efficacy, recognising that the radiation dose received by tumour tissue is a very strong biomarker for response.
The estimated dose distributions will be compared to the original plan for non-inferiority using the dose reconstruction method based on the prostate motion trajectory and the logged MLC positions (beam shapes).
Also, the impact on organs at risk doses due to MLC target tracking.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will undergo radiotherapy using motion management techniques: Triggered Imaging with TrueBeam for prostate cancer, Synchrony with Radixact for prostate cancer, and Synchrony with Radixact for lung cancer. Dosimetric coverage will be assessed after treatment based on the accuracy of the motion management techniques and compared with dose coverage without motion management. After interim analysis, Planning target volume (PTV) will be reduced based on dosimetric accuracy in each arm.
| Arm | Type | Receives |
|---|---|---|
| Triggered Imaging with TrueBeam for prostate cancer | Experimental | Radiation: Triggered imaging on TrueBeam with margin reductionPatients will undergo radiotherapy using the Triggered Imaging technique with TrueBeam for prostate cancer. The technology on the TrueBeam allows for monitoring and gating of the radiation beam in relation to the target position. |
| Synchrony with Radixact for prostate cancer | Experimental | Radiation: Synchrony MLC tracking on fiducials with margin reductionPatients will undergo radiotherapy using the Synchrony technique with Radixact for prostate cancer. Multi-Leaf Collimator Adaptation (MLC) and kilovoltage (kV) Intrafraction Monitoring with the Synchrony technique on the Radixact radiotherapy machine. |
| Synchrony with Radixact for lung cancer | Experimental | Radiation: Synchrony MLC tracking and lung adaptive model with margin reductionPatients will undergo radiotherapy using the Synchrony technique with Radixact for lung cancer. MLC Adaptation, Respiratory Motion Tracking, and kV Intrafraction Monitoring with the adaptive Synchrony technique on the Radixact radiotherapy machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients histologically proven prostate adenocarcinoma
- Prostate specific antigen (PSA) obtained within three months prior to enrollment
- Localised prostate cancer at any stage eligible for radiotherapy: i.e. any T- or Gleason stage, but no pelvic lymph nodes can be included within the target to be treated
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (8 listed)
- Patient must have three gold fiducial markers inserted in the prostate
- Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
- Patients with overlapping implanted gold fiducials in X-ray imaging
- Unfeasible to track fiducials with kv imaging/existing online imaging systems
- Previous treatment with radiotherapy for lung cancer or lung metastasis
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 |
|---|---|---|
| Triggered imaging on TrueBeam with margin reductionAt interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique. | Radiation | Triggered Imaging with TrueBeam for prostate cancer |
| Synchrony MLC tracking on fiducials with margin reductionAt interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique. | Radiation | Synchrony with Radixact for prostate cancer |
| Synchrony MLC tracking and lung adaptive model with margin reductionAt interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique for lung cancer. | Radiation | Synchrony with Radixact for lung cancer |
Primary outcome
Dosemetric accuracy
Time frame: At treatment completion, approximately 1-4 weeks
Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.
4 secondary outcomes
Geometric accuracy
Time frame: At treatment completion, approximately 1-4 weeks
Motion trajectory
Time frame: At treatment completion, approximately 1-4 weeks
Acute Toxicity
Time frame: Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction..
Mechanical & software failure
Time frame: At treatment completion, approximately 1-4 weeks
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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. The data used in this study contains sensitive information about the study participants and they did not provide consent for public data sharing. The current approval by the Swedish Ethical Review Authority does not include data sharing. A minimal data set could be shared by request from a qualified academic investigator for the sole purpose of replicating the present study, provided the data transfer is in agreement with European Union legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority.
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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. This study is not recruiting at the moment.
André Haraldsson, PhD, MPE principal investigator
Skane university hospital, Lund university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triggered imaging on TrueBeam with margin reduction, Synchrony MLC tracking on fiducials with margin reduction and Synchrony MLC tracking and lung adaptive model with margin reduction in people with Cancer of Lung and Lung Metastasis, run by Region Skane 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 14 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosemetric accuracy (time frame: At treatment completion, approximately 1-4 weeks). 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 28 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.