68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer

Fujian Medical University (FJMU)

Status and phase: Enrolling; Early Phase 1

Conditions: Tumor

Treatments: Drug: 68Ga-FAPI/18F-FDG; Drug: 68Ga-DOTA-NI-FAPI04

Study type: Interventional

Funder types: Other

Identifiers

NCT06455761

FirstAHFujian-68Ga-FAPI

Details and patient eligibility

About

As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

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, showing high efficacy in tumor staging and restaging. As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.

Enrollment: 30 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

68Ga-DOTA-NI-FAPI04 PET/ CT

Experimental group

Description:

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT.

Treatment:

Drug: 68Ga-DOTA-NI-FAPI04

68Ga-FAPI/18F-FDG PET/ CT

Experimental group

Description:

Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18FFDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.

Treatment:

Drug: 68Ga-FAPI/18F-FDG