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

Gastrointestinal Cancer Clinical Trial

— GIPSMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547919
• Other study ID #: GI-PSMA22
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: September 2023
• Source: Wuerzburg University Hospital
• Contact: Rudolf A Werner, MD
• Phone: +4993120135001
• Email: werner_r1[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Neoplasms
• Neuroendocrine Tumors

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg	Wuerzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True positive rate per patient specimen	The probability of GEP-NEN is given when immunhistochemistry test is positive.	24 months
Primary	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
Primary	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	Ex-vivo PSMA expression	Expression of PSMA per specimen at immunhistochemistry.	24 months
Secondary	PSMA uptake on 18F-PSMA-1007 PET	Quantified uptake of PSMA per tumor lesion basis.	24 months