Predicting Esophageal Cancer Borders Using PET-Imaging PEGASUS

RADONK-PEGASUS-2023

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.

2024-03-01

2026-01-01

2026-04-01

Recruiting

Early phase I

30

Inclusion Criteria: * 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 Criteria: * 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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-05-09