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Trial Title:
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
NCT ID:
NCT06455761
Condition:
Tumor
Conditions: Official terms:
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-DOTA-NI-FAPI04
Description:
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer
doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT.
Arm group label:
68Ga-DOTA-NI-FAPI04 PET/ CT
Intervention type:
Drug
Intervention name:
68Ga-FAPI/18F-FDG
Description:
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1
mCi)/Kg 18F-FDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by
PET/CT.
Arm group label:
68Ga-FAPI/18F-FDG PET/ CT
Summary:
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04
is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a
FAP-targeting. In this study, we observed the diagnostic performance of
68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its
imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
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 nitroimidazole(NI)-moiety and a
FAP-targeting. In this study, we observed the diagnostic performance of
68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its
imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
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:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibing Miao, MD
Phone:
+86-0591-87981618
Email:
miaoweibing@126.com
Contact backup:
Last name:
Guochang Wang, MD
Phone:
+86-0591-87981619
Email:
guochang1007@163.com
Start date:
April 1, 2024
Completion date:
December 31, 2025
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/NCT06455761
