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

Malignant Neoplasm Clinical Trial

Official title:

68Ga-FAPI-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438250
• Other study ID #: FirstAHFujian-68Ga-FAPI-JH04
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

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