NCT04359732

Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer
• Esophageal Neoplasms

Interventions

Type	Name	Description
OTHER	hybrid PET/MRI	An additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone.

Timeline

• Start date: 2020-05-08
• Primary completion: 2026-02-02
• Completion: 2026-02-28
• First posted: 2020-04-24
• Last updated: 2026-02-06

Locations

1 site across 1 country: Italy