RecruitingPhase 2NCT06408116

Predicting Esophageal Cancer Borders Using PET-Imaging

Predicting Esophageal Cancer Borders Using PET-Imaging PEGASUS


Sponsor

University Hospital Heidelberg

Enrollment

30 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study examines the diagnostic precision of endosonography, mpMRI and PET/CT in defining tumor boundaries and tumor spread before and after neoadjuvant therapy and definitive surgery.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, including AEG I and AEG II tumors in the primary situation
  • Planned surgical treatment of esophageal carcinoma
  • Possible staging advantage through FAPI PET/CT diagnostics
  • Patient information and written consent
  • \> KI 60% or ECOG 0/1 (at least: self-sufficiency)
  • Age ≥ 18 years

Exclusion Criteria9

  • Previous radiation therapy in the tumor region
  • Previous tumor disease with \< 5 years of remission
  • Surgical therapy is not functionally or technically possible
  • Distant metastasis
  • Patient is not capable of giving consent
  • Concurrent participation in another clinical trial that could affect the results of this trial or the other trial
  • Illnesses that do not allow the person concerned to assess the nature and scope as well as possible consequences of the clinical study
  • pregnant or breastfeeding women
  • Signs that the person taking part is unlikely to comply with the therapy (e.g. unwillingness to cooperate)

Interventions

RADIATIONphoton

radiation with 4-5 cm safte margin

PROCEDUREsurgical therapy

surgery based on PET-CT/MRI staging

DRUGChemotherapy

neoadjuvant chemotherapy


Locations(1)

Department of Radiotherapy, University of Heidelberg

Heidelberg, Germany

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NCT06408116


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