PSMA in Gastroenterologic Tumors (GIPSMA)

Wuerzburg University Hospital

Status: Enrolling

Conditions: Gastrointestinal Cancer

Treatments: Radiation: 18F-PSMA PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT05547919

GI-PSMA22

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

46 participants in 1 patient group

Gastroenterologic tumors histologically positive for PSMA

Experimental group

Description:

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.

Treatment:

Radiation: 18F-PSMA PET/CT