Viewing Study NCT06455761



Ignite Creation Date: 2024-06-16 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06455761
Status: RECRUITING
Last Update Posted: 2024-06-12
First Post: 2024-06-07

Brief Title: 68Ga-DOTA-NI-FAPI04 PETCT in Patients With Various Types of Cancer
Sponsor: First Affiliated Hospital of Fujian Medical University
Organization: First Affiliated Hospital of Fujian Medical University

Study Overview

Official Title: 68Ga-DOTA-NI-FAPI04 PETCT in Patients With Various Types of Cancer
Status: RECRUITING
Status Verified Date: 2024-06
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: As a novel radiotracer targeting fibroblast activation protein FAP 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazoleNI-moiety and a FAP-targeting In this study we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PETCT in patients with different types of cancer and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PETCT
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 showing high efficacy in tumor staging and restaging As a novel radiotracer targeting fibroblast activation protein FAP 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazoleNI-moiety and a FAP-targeting In this study we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PETCT in patients with different types of cancer and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PETCT

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