Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-30 @ 6:32 PM
Study NCT ID:
NCT05844761
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-21
First Post:
2023-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-time Motion Management During Prostate and Lung Radiotherapy
Sponsor:
Region Skane
Organization:
Study Overview
Official Title:
Real-time Motion Management During Prostate and Lung Radiotherapy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMIND
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.
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: