A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastroenterologic Tumors

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Wuerzburg
RECRUITING
Würzburg
Contact Information
Primary
Alexander M Weich, MD
weich_A@ukw.de
+4993120140201
Backup
Rudolf A Werner, MD
werner_r4@ukw.de
+4993120135001
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 46
Treatments
Experimental: Gastroenterologic 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.
Sponsors
Leads: Wuerzburg University Hospital

This content was sourced from clinicaltrials.gov