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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06438250
Other study ID # FirstAHFujian-68Ga-FAPI-JH04
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 1, 2024
Est. completion date July 1, 2024

Study information

Verified date April 2024
Source First Affiliated Hospital of Fujian Medical University
Contact Weibing Miao, MD
Phone +86-0591-87981618
Email miaoweibing@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

68Ga-FAPI-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH040182 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-FAPI-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-FAPI-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-FAPI-JH04.


Recruitment information / eligibility

Status Recruiting
Enrollment 5
Est. completion date July 1, 2024
Est. primary completion date June 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 Design


Related Conditions & MeSH terms


Intervention

Drug:
68Ga-FAPI-JH04
The dose will be 148-222 MBq given intravenously.

Locations

Country Name City State
China Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary safety and tolerability The safety evaluation of 68Ga-FAPI-JH04 PET/CT was performed for all patients based on the Common Toxicity Criteria for Adverse Events 5.0 (CTCAE 5.0) from baseline to follow up, including vital signs, health conditions, and laboratory tests. Up to 1 week
Secondary Human biodistribution reported as relative uptake values per organ at 3min, 15min, 30min, 60min and 150 min per individual subject and as a mean over all subjects From right after tracer injection to 150 min at post-injection
Secondary Human dosimetry radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects. Dosimetry will be calculated using the Hybrid-Dosimetry software. From right after tracer injection to 150 min at post-injection
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