PSMA in Gastroenterologic Tumors (GIPSMA)

Recruiting now · Not applicable

Conditions studied: Gastrointestinal Cancer

In brief

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.

Key facts

Study ID

NCT05547919

Run by

Wuerzburg University Hospital

People needed

46

Starts

2022-10-01

Expected to finish

2026-10-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with newly diagnosed GET prior to initiation of guideline-compatible, anti-tumor therapy
• Available tissue specimen to conduct PSMA expression profiling
• Male/female, above 18 years old
• Patients must provide written informed consent
• Patients must be willing to comply with study procedures and available for follow-up examinations

You may not qualify if…

• Curative setting
• Not sufficient tumor tissue available
• Male Patients: No prostate carcinoma
• Other malignant neoplasms in patient's history
• Pregnancy or Breastfeeding
• Contraindications for PET/CT

Where it is running

• University Hospital Wuerzburg — Würzburg, Bavaria, Germany (enrolling)

Full record on ClinicalTrials.gov

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