PSMA in Gastroenterologic Tumors (GIPSMA)

NCT05547919 | Recruiting

• 1 other identifier: GI-PSMA22
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• True positive rate per patient specimen

  The probability of GET is given when immunhistochemistry test is positive.

  24 months

• True positive rate per patient

  The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.

  24 months

• Number of patients with identified tumor lesion sites

  To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GET to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.

  24 months

Secondary Outcomes (2)

• Ex-vivo PSMA expression

  24 months

• PSMA uptake on 18F-PSMA-1007 PET

  24 months

Study Arms (1)

Gastroenterologic tumors histologically positive for PSMA

EXPERIMENTAL

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.

Radiation: 18F-PSMA PET/CT

Interventions

18F-PSMA PET/CT RADIATION

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

Gastroenterologic tumors histologically positive for PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Alexander M Weich, MD

CONTACT

+4993120140201; weich_A@ukw.de

Rudolf A Werner, MD

CONTACT

+4993120135001; werner_r4@ukw.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 21, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)