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Trial Title:
68Ga-JH04 PET/CT: Dosimetry and Biodistribution Studies
NCT ID:
NCT06438250
Condition:
Malignant Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Drug: 68Ga-JH04
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-JH04
Description:
The dose will be 148-222 MBq given intravenously.
Arm group label:
dynamic PET scans
Summary:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibing Miao, MD
Phone:
+86 591 87981618
Email:
miaoweibing@126.com
Contact backup:
Last name:
Guochang Wang, MD
Phone:
+86 591 87981619
Email:
guochang1007@163.com
Start date:
March 1, 2024
Completion date:
October 1, 2024
Lead sponsor:
Agency:
First Affiliated Hospital of Fujian Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06438250
