PSMA in Gastroenterologic Tumors (GIPSMA)

NCT ID: NCT05547919

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-10-01

Brief Summary

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

Gastrointestinal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gastroenterologic tumors histologically positive for PSMA

Tumor biopsy at baseline to establish diagnosis and to identify PSMA expression in an ex-vivo setting. Patients with ex-vivo PSMA expression receive a multimodal imaging approach: This includes a PSMA-targeted PET/CT (18F-PSMA) at baseline and conventional imaging.

Group Type: EXPERIMENTAL

18F-PSMA PET/CT

Intervention Type: RADIATION

Patients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.

Interventions

18F-PSMA PET/CT

Patients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuerzburg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Wuerzburg

Würzburg, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Alexander M Weich, MD

Role: CONTACT

weich_A@ukw.de

+4993120140201

Rudolf A Werner, MD

Role: CONTACT

werner_r4@ukw.de

+4993120135001

Facility Contacts

Alexander M Weich, MD

Role: primary

weich_a@ukw.de

+4993120140201

Rudolf A Werner, MD

Role: backup

werner_r1@ukw.de

+4993120135001

Other Identifiers

GI-PSMA22

Identifier Type: -

Identifier Source: org_study_id