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

Esophageal Cancer Clinical Trial

— Escape  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04359732
• Other study ID #: Escape
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Francesco De Cobelli, MD
• Phone: +3926432529
• Email: decobelli.francesco[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: June 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	Deaprtment of Radiology, IRCCS Ospedale San Raffaele	Milano

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Associazione Italiana per la Ricerca sul Cancro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to neoadjuvant treatment -MRI	MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints	0-36 months
Primary	Response to neoadjuvant treatment -PET	PET component -quantitative evaluation and delta between timepoints	0-36 months
Primary	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
Primary	Response to neoadjuvant treatment -Radiomics	Radiomic features extracted from hybrid imaging	0-36 months
Primary	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	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