Clinical trial NCT04359732: Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI
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
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Esophageal Neoplasms
Keywords: response
neoadjuvant
PET/MRI
radiomics
GEJ cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Associazione Italiana per la Ricerca sul Cancro
First posted: 2020-04-24
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Response to neoadjuvant treatment -MRI
timeFrame: 0-36 months
measure: Response to neoadjuvant treatment -PET
timeFrame: 0-36 months
measure: Response to neoadjuvant treatment - Histology
timeFrame: 0-36 months
measure: Response to neoadjuvant treatment -Radiomics
timeFrame: 0-36 months
measure: Imaging parameters as potential predictors of tumor response
timeFrame: 0- 48 months
Secondary outcomes:
measure: Early regression model (ERI)
timeFrame: 0- 60 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Deaprtment of Radiology, IRCCS Ospedale San Raffaele
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Francesco De Cobelli, MD
role: PRINCIPAL_INVESTIGATOR
References: