Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05547919

PSMA in Gastroenterologic Tumors (GIPSMA)

Led by Wuerzburg University Hospital · Updated on 2025-09-29

46

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PSMA in Gastroenterologic Tumors (GIPSMA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with newly diagnosed gastroenterologic tumors before starting guideline-compatible anti-tumor therapy
  • Available tissue specimen for PSMA expression profiling
  • Male or female patients aged 18 years or older
  • Patients able and willing to provide written informed consent
  • Patients willing to follow study procedures and available for follow-up examinations
Not Eligible

You will not qualify if you...

  • Patients in a curative treatment setting
  • Insufficient tumor tissue available for analysis
  • Male patients without prostate carcinoma
  • History of other malignant cancers
  • Pregnancy or breastfeeding
  • Contraindications to PET/CT imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Wuerzburg

Würzburg, Bavaria, Germany, 97080

Actively Recruiting

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Research Team

A

Alexander M Weich, MD

CONTACT

R

Rudolf A Werner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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