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NCT Number: NCT05547919

PSMA in Gastroenterologic Tumors (GIPSMA)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-PSMA PET/CT

Radiation

Patients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET/CT to routine imaging.

Primary outcomes

  1. True positive rate per patient specimen

    Time frame: 24 months

    The probability of GET is given when immunhistochemistry test is positive.

  2. True positive rate per patient

    Time frame: 24 months

    The probability of GET is given when 18F-PSMA-1007 PET/CT is positive on a per patient basis.

  3. Number of patients with identified tumor lesion sites

    Time frame: 24 months

    To compare the sites of disease identified on 18F-PSMA-1007 PET/CT in patients with GET to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET/CT.

Secondary outcomes

  1. Ex-vivo PSMA expression

    Time frame: 24 months

    Expression of PSMA per specimen at immunhistochemistry.

  2. PSMA uptake on 18F-PSMA-1007 PET

    Time frame: 24 months

    Quantified uptake of PSMA per tumor lesion basis.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander M Weich, MD

CONTACT

[email protected]

+4993120140201

Rudolf A Werner, MD

CONTACT

[email protected]

+4993120135001

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

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

Acronym: GIPSMA

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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