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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Drug: 68Ga-JH04

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Weibing Miao, MD; Phone Number: +86-0591-87981618; Email: miaoweibing@126.com
• Study Contact Backup: Name: Guochang Wang, PhD; Phone Number: +86-0591-87981619; Email: guochang1007@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Recruiting
      • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
      • Contact: Weibing Miao, MD; Phone Number: +86 591 87981618; Email: miaoweibing@126.com
      • Contact: Guochang Wang, MD; Phone Number: +86 591 87981619; Email: guochang1007@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dynamic PET scans; PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection	Drug: 68Ga-JH04; The dose will be 148-222 MBq given intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerability	Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.	Up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human biodistribution	reported as relative uptake values per organ at 3 minutes, 15 minutes, 30 minutes, 60 minutes and 150 minutes per individual subject and as a mean over all subjects	From right after tracer injection to 150 minutes at post-injection
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 minutes at post-injection

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University
• Investigators: Principal Investigator: Weibing Miao, MD, the First Affiliated Hospital, Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 27, 2024
• First Submitted That Met QC Criteria: May 27, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FirstAHFujian-68Ga-JH04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No