Real-time Motion Management During Prostate and Lung Radiotherapy

Cancer of Prostate Clinical Trial

— REMIND  

Official title:

Real-time Motion Management During Prostate and Lung Radiotherapy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05844761
• Other study ID #: 2022-05273-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 132
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Lung
• Cancer of Prostate
• Lung Metastasis
• Lung Neoplasms
• Prostatic Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Skåne University Hospital	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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..
Secondary	Mechanical & software failure	The percentage of fractions delivered without software or mechanical failure	At treatment completion, approximately 1-4 weeks