Back to resultsReal-time Motion Management During Prostate and Lung Radiotherapy (REMIND)
Primary Purpose
Cancer of Lung, Lung Metastasis, Cancer of Prostate
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Lung
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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
Sites / Locations
- Skåne University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Triggered Imaging with TrueBeam for prostate cancer
Synchrony with Radixact for prostate cancer
Synchrony with Radixact for lung cancer
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Dosemetric accuracy
Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.
Secondary Outcome Measures
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)
Motion trajectory
Motion trajectory measured by kilovoltage imaging, including any prediction algorithms compared to without latency and other limitations compared with MAE.
Acute Toxicity
EORTC guided and physician assessed
Mechanical & software failure
The percentage of fractions delivered without software or mechanical failure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05844761
Brief Title
Real-time Motion Management During Prostate and Lung Radiotherapy
Acronym
REMIND
Official Title
Real-time Motion Management During Prostate and Lung Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Lung, Lung Metastasis, Cancer of Prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Triggered Imaging with TrueBeam for prostate cancer
Arm Type
Experimental
Arm Description
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.
Arm Title
Synchrony with Radixact for prostate cancer
Arm Type
Experimental
Arm Description
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.
Arm Title
Synchrony with Radixact for lung cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Triggered imaging on TrueBeam with margin reduction
Intervention Description
At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique.
Intervention Type
Radiation
Intervention Name(s)
Synchrony MLC tracking on fiducials with margin reduction
Intervention Description
At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique.
Intervention Type
Radiation
Intervention Name(s)
Synchrony MLC tracking and lung adaptive model with margin reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dosemetric accuracy
Description
Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.
Time Frame
At treatment completion, approximately 1-4 weeks
Secondary Outcome Measure Information:
Title
Geometric accuracy
Description
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)
Time Frame
At treatment completion, approximately 1-4 weeks
Title
Motion trajectory
Description
Motion trajectory measured by kilovoltage imaging, including any prediction algorithms compared to without latency and other limitations compared with MAE.
Time Frame
At treatment completion, approximately 1-4 weeks
Title
Acute Toxicity
Description
EORTC guided and physician assessed
Time Frame
Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction..
Title
Mechanical & software failure
Description
The percentage of fractions delivered without software or mechanical failure
Time Frame
At treatment completion, approximately 1-4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Haraldsson, PhD, MPE
Organizational Affiliation
Skane university hospital, Lund university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skåne University Hospital
City
Lund
State/Province
Skåne
ZIP/Postal Code
21185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
<1y after study. At least 5 years
IPD Sharing Access Criteria
On request and as supplementary at publication
Learn more about this trial
Real-time Motion Management During Prostate and Lung Radiotherapy
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