Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438250
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-27
Brief Title:
68Ga-JH04 PETCT Dosimetry and Biodistribution Studies
Sponsor:
First Affiliated Hospital of Fujian Medical University
Organization:
First Affiliated Hospital of Fujian Medical University
Study Overview
Official Title:
68Ga-JH04 PETCT Dosimetry and Biodistribution Study in Patients With Various Cancers
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None