68Ga-JH04 PET/CT: Dosimetry and Biodistribution Studies

Fujian Medical University (FJMU)

Status and phase: Enrolling; Early Phase 1

Conditions: Malignant Neoplasm

Treatments: Drug: 68Ga-JH04

Study type: Interventional

Funder types: Other

Identifiers

NCT06438250

FirstAHFujian-68Ga-JH04

Details and patient eligibility

About

68Ga-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 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-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-JH04.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ 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)

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5 participants in 1 patient group

dynamic PET scans

Experimental group

Description:

PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection

Treatment:

Drug: 68Ga-JH04