Real-time Motion Management During Prostate and Lung Radiotherapy

Not Applicable

• Conditions: Lung Metastasis; Cancer of Lung; Cancer of Prostate
• Interventions: Radiation: Triggered imaging on TrueBeam with margin reduction; Radiation: Synchrony MLC tracking and lung adaptive model with margin reduction; Radiation: Synchrony MLC tracking on fiducials with margin reduction

• Registration Number: NCT05844761
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-25
• Study Start: 2023-05-01
• Study First Posted: 2023-05-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triggered Imaging with TrueBeam for prostate cancer	Triggered imaging on TrueBeam with margin reduction	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.
Synchrony with Radixact for lung cancer	Synchrony MLC tracking and lung adaptive model with margin reduction	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.
Synchrony with Radixact for prostate cancer	Synchrony MLC tracking on fiducials with margin reduction	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.

Primary Outcome Measures

Name	Time	Method
Dosemetric accuracy	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.

Secondary Outcome Measures

Name	Time	Method
Acute Toxicity	Baseline prior to first fraction. At end of radiotherapy (1-4 weeks) and at 3 months after last fraction..	EORTC guided and physician assessed
Geometric accuracy	At treatment completion, approximately 1-4 weeks	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	At treatment completion, approximately 1-4 weeks	Motion trajectory measured by kilovoltage imaging, including any prediction algorithms compared to without latency and other limitations compared with MAE.
Mechanical & software failure	At treatment completion, approximately 1-4 weeks	The percentage of fractions delivered without software or mechanical failure

Trial Locations

Locations (1)

Skåne University Hospital; 🇸🇪 Lund, Skåne, Sweden