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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

Study details
    Gastrointestinal Cancer

NCT05547919

Wuerzburg University Hospital

28 January 2024

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