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

Not Applicable

Recruiting

• Conditions: Gastrointestinal Cancer
• Interventions: Radiation: 18F-PSMA PET/CT

• Registration Number: NCT05547919
• Lead Sponsor: Wuerzburg University Hospital

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-21
• Study Start: 2022-10-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastrointestinal tumors histologically positive for PSMA	18F-PSMA PET/CT	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.

Primary Outcome Measures

Name	Time	Method
True positive rate per patient	24 months	The probability of GEP-NEN is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.
True positive rate per patient specimen	24 months	The probability of GEP-NEN is given when immunhistochemistry test is positive.
Number of patients with identified tumor lesion sites	24 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Bavaria, Germany