68Ga-JH04 PET/CT: Dosimetry and Biodistribution Studies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-JH04.
- Who it may be relevant to
- Registry conditions: Malignant Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
68Ga-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers
Overview
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.
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.
Interventions
- Drug 68Ga-JH04
The dose will be 148-222 MBq given intravenously.
Primary outcome measures
- safety and tolerability [Time frame: Up to 1 week]
Secondary outcome measures (2)
- Human biodistribution [Time frame: From right after tracer injection to 150 minutes at post-injection]
- Human dosimetry [Time frame: From right after tracer injection to 150 minutes at post-injection]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou
Identifiers
NCT: NCT06438250 · FirstAHFujian-68Ga-JH04