Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT06414902
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2024-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chemoradiation Treatment Response in Esophageal Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chemoradiation Treatment Response in Esophageal Cancer
Status:
RECRUITING
Status Verified Date:
2025-11
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:
To learn if 18F-FAraG PET scans can find tumors in participants with esophageal cancer and predict a participant's response to treatment.
Detailed Description:
Primary Objectives
* Evaluate the ability of 18F-FAraG PET imaging to detect tumors in participants with esophageal cancer;
* Evaluate 18F-FAraG PET as a predictor of pathologic complete response
Secondary Objectives
* Evaluate the correlation of 18F-FAraG PET with clinical characteristics
* Evaluate the correlation of 18F-FAraG PET with scRNA-seq data
* Evaluate tissue and blood biomarkers as predictors of treatment response and disease recurrence
* Evaluate functional imaging with 18F-FAraG PET and tissue and blood biomarkers as predictors of overall survival and disease-free survival
* Compare 18F-FAraG PET SUV update to the change in standard 18FDG-PET SUV parameters before and after chemoradiation.
* Evaluate the ability of 18F-FAraG PET imaging to detect tumors in participants with esophageal cancer;
* Evaluate 18F-FAraG PET as a predictor of pathologic complete response
Secondary Objectives
* Evaluate the correlation of 18F-FAraG PET with clinical characteristics
* Evaluate the correlation of 18F-FAraG PET with scRNA-seq data
* Evaluate tissue and blood biomarkers as predictors of treatment response and disease recurrence
* Evaluate functional imaging with 18F-FAraG PET and tissue and blood biomarkers as predictors of overall survival and disease-free survival
* Compare 18F-FAraG PET SUV update to the change in standard 18FDG-PET SUV parameters before and after chemoradiation.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-04295 | OTHER | NCI-CTRP Clinical Registry | View |