Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604533
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Magnetic Resonance Imaging MRI Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Phase II Trial - Magnetic Resonance Imaging MRI Guided Stereotactic Adaptive Radiotherapy for Targeting Abdominal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the effect of MRI-guided adaptive stereotactic radiotherapy on local control survival and toxicity in the treatment of oligometastatic cancer to the abdomen
Detailed Description:
This is an Australian-led multi-centre Phase 2 randomised controlled trial The aim of this study is to investigate the effect of MRI-guided adaptive stereotactic radiotherapy on LC survival and toxicity in the treatment of oligometastatic cancer to the abdomen
This study will provide one of the first high level phase 2 randomised evidence required to demonstrate this new technology improves patient clinical outcomes and inform the selection of patients for MRI-Linac treatment
The primary objective is to evaluate the effect of MRI-guided adaptive stereotactic radiotherapy on 2 year LC of treated lesions in patients with abdominal oligometastatic or primary liver cancer
Aim 1 Quantify the effect of MRI-guided stereotactic radiotherapy on patient outcomes Patient outcomes will be determined by measuring LC survival and safety toxicity
Aim 2 Quantify patient dose and cancer targeting accuracy The ability of MRI-Linacs to treat more patients to a higher dose than standard linacs through adaptive dose-escalation and improved target coverage will be quantified The delivered dose for each treatment arm will be compared
Aim 3 Explore functional MRI biomarkers of radiotherapy response prediction Candidate functional biomarkers of tumour perfusion and diffusion will be identified
This study will provide one of the first high level phase 2 randomised evidence required to demonstrate this new technology improves patient clinical outcomes and inform the selection of patients for MRI-Linac treatment
The primary objective is to evaluate the effect of MRI-guided adaptive stereotactic radiotherapy on 2 year LC of treated lesions in patients with abdominal oligometastatic or primary liver cancer
Aim 1 Quantify the effect of MRI-guided stereotactic radiotherapy on patient outcomes Patient outcomes will be determined by measuring LC survival and safety toxicity
Aim 2 Quantify patient dose and cancer targeting accuracy The ability of MRI-Linacs to treat more patients to a higher dose than standard linacs through adaptive dose-escalation and improved target coverage will be quantified The delivered dose for each treatment arm will be compared
Aim 3 Explore functional MRI biomarkers of radiotherapy response prediction Candidate functional biomarkers of tumour perfusion and diffusion will be identified
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None