Real-time Motion Management During Prostate and Lung Radiotherapy

NCT ID: NCT05844761

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-12-31

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.

Conditions

Cancer of Lung; Lung Metastasis; Cancer of Prostate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Triggered imaging on TrueBeam with margin reduction

Intervention Type: RADIATION

At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the TrueBeam triggered imaging motion management technique.

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.

Group Type: EXPERIMENTAL

Synchrony MLC tracking on fiducials with margin reduction

Intervention Type: RADIATION

At interim analysis the Planning target volume (PTV) will be reduced based on the accuracy of the Radixact Synchrony motion management technique.

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.

Group Type: EXPERIMENTAL

Synchrony MLC tracking and lung adaptive model with margin reduction

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

André Änghede Haraldsson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

André Haraldsson, PhD, MPE

Role: PRINCIPAL_INVESTIGATOR

Skane university hospital, Lund university

Locations

Skåne University Hospital

Lund, Skåne County, Sweden

Countries

Sweden

Other Identifiers

2022-05273-01

Identifier Type: -

Identifier Source: org_study_id