Status:
RECRUITING
Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Associazione Italiana per la Ricerca sul Cancro
Conditions:
Esophageal Cancer
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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 regim...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT04359732
Start Date
May 8 2020
End Date
October 31 2025
Last Update
February 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Deaprtment of Radiology, IRCCS Ospedale San Raffaele
Milan, Milano, Italy, 20132