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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Early Phase 1

Conditions: Malignant Neoplasm

Treatments: Drug: 68Ga-NI-FAPI

Study type: Interventional

Funder types: Other

Identifiers

NCT06688305

FirstAHFujian-68Ga-NI-FAPI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

68Ga-NI-FAPI PET/CT

Experimental group

Description:

PET/CT imaging in patients with malignant tumors: each patient underwent a PET/CT scan after intravenous administration of 68Ga-NI-FAPI.

Treatment:

Drug: 68Ga-NI-FAPI