Escape: Prediction of Assessment of Response to nCRT for Esophageal and Gastroesophageal Junction Cancer Using a Fully Integrated PET/MRI

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT04359732

Collaborator

AIRC -FONDAZIONE AIRC PER LA RICERCA SUL CANCRO (Other)

155

Enrollment

Location

Arm

55.8

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Esophageal Neoplasms	Other: hybrid PET/MRI	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

155 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

May 8, 2020

Anticipated Primary Completion Date :

May 16, 2023

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Early regression model (ERI) [0- 60 months]
Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.