PSMA in Gastrointestinal Tumors (GIPSMA, Focusing on Neuroendocrine Neoplasms) (GIPSMA)

A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastrointestinal Tumors (Focusing on Neuroendocrine Neoplasms)

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. Gastrointestinal tumors (GIT), including gastroenteropancreatic neuroendocrine neoplasms (GEP-NEN) 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 GEP-NEN 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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Radiation: 18F-PSMA PET/CT

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rudolf A Werner, MD; Phone Number: +4993120135001; Email: werner_r1@ukw.de
• Study Contact Backup: Name: Alexander M Weich, MD; Phone Number: +4993120140201; Email: weich_a@ukw.de

Study Locations

• Germany
  • Bavaria
    • Wuerzburg, Bavaria, Germany, 97080
      • Recruiting
      • University Hospital Wuerzburg
      • Contact: Rudolf A Werner, MD; Phone Number: +4993120135001; Email: werner_r1@ukw.de
      • Contact: Alexander M Weich, MD; Phone Number: +4993120140201; Email: weich_a@ukw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with newly diagnosed GEP-NEN 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastrointestinal 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.	Radiation: 18F-PSMA PET/CT; Patients with metastasized gastrointestinal tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
True positive rate per patient specimen	The probability of GEP-NEN is given when immunhistochemistry test is positive.	24 months
True positive rate per patient	The probability of GEP-NEN 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 GEP-NEN to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ex-vivo PSMA expression	Expression of PSMA per specimen at immunhistochemistry.	24 months
PSMA uptake on 18F-PSMA-1007 PET	Quantified uptake of PSMA per tumor lesion basis.	24 months

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Gastrointestinal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neuroendocrine Tumors
• Other Study ID Numbers: GI-PSMA22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No