Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06438250

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-JH04

Drug

The dose will be 148-222 MBq given intravenously.

Primary outcomes

  1. safety and tolerability

    Time frame: Up to 1 week

    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.

Secondary outcomes

  1. Human biodistribution

    Time frame: From right after tracer injection to 150 minutes at post-injection

    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

  2. Human dosimetry

    Time frame: From right after tracer injection to 150 minutes at post-injection

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guochang Wang, PhD

CONTACT

[email protected]

+86-0591-87981619

Weibing Miao, MD

CONTACT

[email protected]

+86-0591-87981618

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.