Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
Study NCT ID:
NCT04359732
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2020-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI
Sponsor:
IRCCS San Raffaele
Organization:
Study Overview
Official Title:
Prediction of Assessment of Response to Neoadjuvant Chemo-Radio-Therapy (nCRT) for Esophageal and Gastroesophageal Junction Cancer (GEJ) Using a Fully Integrated PET/MRI
Status:
RECRUITING
Status Verified Date:
2025-02
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:
Escape
Brief Summary:
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
Detailed Description:
This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.
The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.
* PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)
* An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT
* Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.
* 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT
* Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.
The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.
* PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)
* An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT
* Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.
* 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT
* Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.
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?: