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68Ga-NI-FAPI PET/CT: First-in-human Study

68Ga-NI-FAPI PET/CT: First-in-human Study

Recruiting
18-80 years
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.

Description

Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer.

Eligibility

Inclusion Criteria:

  • Various solid tumors with available histopathological findings
  • Signed informed consent

Exclusion Criteria:

  • pregnant or lactational women
  • who suffered from severe hepatic and renal insufficiency

Study details
    Malignant Neoplasm

NCT06688305

First Affiliated Hospital of Fujian Medical University

15 October 2025

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