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

Prediction of Assessment of Response to Neoadjuvant Chemo-Radio-Therapy (nCRT) for Esophageal and Gastroesophageal Junction Cancer (GEJ) Using a Fully Integrated PET/MRI

Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).

Study Overview

• Status: Active, not recruiting
• Conditions: Esophageal Cancer; Esophageal Neoplasms
• Intervention / Treatment: Other: hybrid PET/MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Deaprtment of Radiology, IRCCS Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (AC) or squamous cell carcinoma (SCC) for which an Ivor-Lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated;
• visible tumor on pre-treatment imaging;
• ≥ 18 years of age;
• signed informed consent.

Exclusion Criteria:

• - incomplete preoperative imaging assessment;
• contraindications to neoadjuvant treatment;
• contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents);
• inability to complete imaging examinations (i.e. severe claustrophobia);
• contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed));
• pregnant or lactating women
• severe hypersensitivity to gadobutrol or fludeoxyglucose F18.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hybrid PET/MRI; For the purposes of the study, in addition to standard imaging (EUS and CT scan), a fully integrated hybrid PET/MRI (PET/MRI) study with FDG will replace the Standard PET (pre-surgical evaluation) used for evaluating distant metastases and will be considered as the add-on procedure at three time points. The additional evaluation for patients is that during nCRT treatment.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response to neoadjuvant treatment -MRI	MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints	0-36 months
Response to neoadjuvant treatment -PET	PET component -quantitative evaluation and delta between timepoints	0-36 months
Response to neoadjuvant treatment - Histology	Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry	0-36 months
Response to neoadjuvant treatment -Radiomics	Radiomic features extracted from hybrid imaging	0-36 months
Imaging parameters as potential predictors of tumor response	Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment	0- 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early regression model (ERI)	Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment	0- 60 months

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Collaborators: Associazione Italiana per la Ricerca sul Cancro
• Investigators: Principal Investigator: Francesco De Cobelli, MD, Irccs Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2020
• Primary Completion (Estimated): February 2, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: neoadjuvant; response; GEJ cancer; PET/MRI; radiomics
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: Escape

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No