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

Primary Purpose

Esophageal Cancer, Esophageal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hybrid PET/MRI
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophageal Cancer focused on measuring response, neoadjuvant, PET/MRI, radiomics, GEJ cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Deaprtment of Radiology, IRCCS Ospedale San RaffaeleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hybrid PET/MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Early regression model (ERI)
Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment

Full Information

First Posted
April 20, 2020
Last Updated
January 24, 2023
Sponsor
IRCCS San Raffaele
Collaborators
Associazione Italiana per la Ricerca sul Cancro
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1. Study Identification

Unique Protocol Identification Number
NCT04359732
Brief Title
Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
Collaborators
Associazione Italiana per la Ricerca sul Cancro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Esophageal Neoplasms
Keywords
response, neoadjuvant, PET/MRI, radiomics, GEJ cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid PET/MRI
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
hybrid PET/MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response to neoadjuvant treatment -MRI
Description
MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints
Time Frame
0-36 months
Title
Response to neoadjuvant treatment -PET
Description
PET component -quantitative evaluation and delta between timepoints
Time Frame
0-36 months
Title
Response to neoadjuvant treatment - Histology
Description
Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry
Time Frame
0-36 months
Title
Response to neoadjuvant treatment -Radiomics
Description
Radiomic features extracted from hybrid imaging
Time Frame
0-36 months
Title
Imaging parameters as potential predictors of tumor response
Description
Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment
Time Frame
0- 48 months
Secondary Outcome Measure Information:
Title
Early regression model (ERI)
Description
Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment
Time Frame
0- 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco De Cobelli, MD
Phone
+3926432529
Email
decobelli.francesco@hsr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Steidler
Phone
+3926436111
Email
steidler.stephanie@hsr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco De Cobelli, MD
Organizational Affiliation
IRCCS Ospedale San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deaprtment of Radiology, IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Steidler, PhD
Phone
+390226436111
Email
steidler.stephanie@hsr.it
First Name & Middle Initial & Last Name & Degree
Francesco De Cobelli, MD
First Name & Middle Initial & Last Name & Degree
Riccardo Rosati, MD

12. IPD Sharing Statement

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

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