Real-time Motion Management During Prostate and Lung Radiotherapy (REMIND)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer of Lung; Cancer of Prostate; Lung Metastasis
• Intervention / Treatment: Radiation: Triggered imaging on TrueBeam with margin reduction; Radiation: Synchrony MLC tracking on fiducials with margin reduction; Radiation: Synchrony MLC tracking and lung adaptive model with margin reduction

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 Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 21185
      • Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triggered Imaging with TrueBeam for prostate cancer; 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.	Radiation: Triggered imaging on TrueBeam with margin reduction; At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique.
Experimental: Synchrony with Radixact for prostate cancer; 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.	Radiation: Synchrony MLC tracking on fiducials with margin reduction; At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique.
Experimental: Synchrony with Radixact for lung cancer; 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.	Radiation: Synchrony MLC tracking and lung adaptive model with margin reduction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosemetric accuracy	Dose coverage defined as dose to 99% of clinical target volume (CTV) (D99%) to target including margin for other uncertainties.	At treatment completion, approximately 1-4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	At treatment completion, approximately 1-4 weeks
Acute Toxicity	EORTC guided and physician assessed	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	At treatment completion, approximately 1-4 weeks

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: André Haraldsson, PhD, MPE, Skane University Hospital, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2022-05273-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No