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Search / Trial NCT04359732

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

Launched by IRCCS SAN RAFFAELE · Apr 21, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Response Neoadjuvant Pet/Mri Radiomics Gej Cancer

ClinConnect Summary

This clinical trial is looking at how a special type of imaging called PET/MRI can help doctors predict how well patients with esophageal or junctional cancers will respond to a specific treatment called neoadjuvant chemoradiotherapy (nCRT). This treatment is often given before surgery to shrink the tumor. By using this advanced imaging technique, researchers hope to better understand which patients might benefit the most from nCRT before they undergo surgery.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of esophageal or junctional cancer that requires surgery. They should also have visible tumors on their pre-treatment scans. However, some people may not qualify if they have certain health issues, allergies to imaging substances, or if they cannot undergo the necessary imaging tests. Participants in this study can expect to undergo PET/MRI scans and receive careful monitoring throughout the trial to assess their response to the treatment. This research aims to improve treatment decisions for future patients with similar cancers.

Gender

ALL

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.

About Irccs San Raffaele

IRCCS San Raffaele is a prestigious research hospital and clinical trial sponsor based in Milan, Italy, renowned for its commitment to advancing medical science through innovative research and high-quality patient care. As an Institute for Research and Healthcare, it specializes in a wide range of therapeutic areas, including oncology, neurology, and cardiology, and is dedicated to translating scientific discoveries into effective clinical practices. With a multidisciplinary team of experts and state-of-the-art facilities, IRCCS San Raffaele plays a pivotal role in conducting rigorous clinical trials that contribute to the development of novel treatments and improve patient outcomes globally.

Locations

Milano, , Italy

Patients applied

0 patients applied

Trial Officials

Francesco De Cobelli, MD

Principal Investigator

IRCCS Ospedale San Raffaele

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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