Clinical Trial · NCT05547919

PSMA in Gastroenterologic Tumors (GIPSMA)

Overview

The theranostic principle is based on the use of radiolabeled compounds which can be applied for diagnostic molecular imaging and targeted delivery of radiation to the tumor. Gastroenterologic tumors (GET), including hepatocellular Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Cholangiocellular Carcinoma, gastroenteropancreatic neuroendocrine neoplasms also express a phenotypic biomarker called prostate-specific membrane antigen (PSMA), thereby rendering it a potential diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy. Aim is to evaluate whether PSMA-directed in-vivo imaging can be also applied to GET patients to determine if i) biopsy-derived tissue of newly diagnosed patients exhibit a PSMA expression profile, ii) PSMA-PET shows upregulated PSMA expression in-vivo, iii) such a molecular imaging approach identifies more disease sites relative to conventional imaging, and iv) if the PSMA PET signal predicts further clinical course and outcome under guideline-compatible treatment.

Sponsor

Aalborg University Hospital

Phase

N/A

Contacts

Rudolf A Werner, MD (CONTACT)

werner_r4@ukw.de

+4993120135001

Alexander M Weich, MD (CONTACT)

weich_a@ukw.de

+4993120140201

ClinicalTrials.gov

NCT05547919

Eligibility

Inclusion

  • Patients must be willing to comply with study procedures and available for follow-up examinations
  • Patients with newly diagnosed GET prior to initiation of guideline-compatible, anti-tumor therapy
  • Available tissue specimen to conduct PSMA expression profiling

Exclusion

  • Other malignant neoplasms in patient's history
  • Contraindications for PET/CT
  • Not sufficient tumor tissue available
  • Pregnancy or Breastfeeding
  • Curative setting