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

NCT04359732 | Active Not Recruiting

• 1 other identifier: Escape
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer; Esophageal Neoplasms

Keywords

response; neoadjuvant; PET/MRI; radiomics; GEJ cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Early regression model (ERI)

  0- 60 months

Study Arms (1)

Hybrid PET/MRI

OTHER

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

Interventions

hybrid PET/MRI OTHER

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.

Hybrid PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Associazione Italiana per la Ricerca sul Cancro: collaborator

Study Sites (1)

Deaprtment of Radiology, IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Francesco De Cobelli, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Chair Radiology Department

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: May 8, 2020
• Primary Completion: February 2, 2026
• Study Completion: February 28, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

IT (1)