Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586892
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI As a Metric of Orodental Injury After Radiotherapy QI-ProVE-MRI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI As a Metric of Orodental Injury After Radiotherapy QI-ProVE-MRI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
QI-ProVE-MRI
Brief Summary:
This research will focus on the prospective qualification and validation of dynamic contrast-enhanced magnetic resonance imaging DCE-MRI candidate biomarkers ie Ktrans and Ve to assess the natural history of osteoradionecrosis ORN and treatment for this devastating complication related to irradiation of head and neck cancers The investigations will also include assessment of DCE-MRI candidate biomarkers for pre-qualification as quantitative imaging biomarkers of soft-tissue structures
Detailed Description:
This prospective observational study will acquire DCE-MRI data from 200 evaluable patients specifically with an elevated dosimetric risk to assure an event rate of 20 by 36 months post-radiation sufficient to demonstrate biomarker performance in the clinical cohort most reflective of relative ORN risk The final study cohort will consist of individuals undergoing definitive radiotherapy for primary head and neck malignancy The study subjects will include patients with primarily elevated risk of ORN based on clinical eg pre-RT dental procedures and dosimetric risk factors we established in prior work eg D30gt50Gy V44 42 or V58 25 All subjects will receive standard IMRT or IMPT as part of their standard clinical care and treatment plans delivered will be in no way modified based on experimental imaging Multi-parametric DCE-MRI imaging will be serially performed as per this studys manual of procedures Clinical data regarding for evaluation of possible dental mandibular as well as other normal tissue organs-at-risk side effects will be collected prospectively from medical and dental records for correlation with the DCE-MRI imaging biomarkers Functional outcomes and patient-reported outcomes questionnaires will be completed to detail outcomes of the continuum of treatment and survivorship
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