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NCT Number: NCT04359732

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

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deaprtment of Radiology, IRCCS Ospedale San Raffaele

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Response to neoadjuvant treatment -MRI

    Time frame: 0-36 months

    MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints

  2. Response to neoadjuvant treatment -PET

    Time frame: 0-36 months

    PET component -quantitative evaluation and delta between timepoints

  3. Response to neoadjuvant treatment - Histology

    Time frame: 0-36 months

    Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry

  4. Response to neoadjuvant treatment -Radiomics

    Time frame: 0-36 months

    Radiomic features extracted from hybrid imaging

  5. Imaging parameters as potential predictors of tumor response

    Time frame: 0- 48 months

    Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment

Secondary outcomes

  1. Early regression model (ERI)

    Time frame: 0- 60 months

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

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

Registry information

Official study 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

Acronym: Escape

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2020
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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