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NCT06455761 Clinical Trial

68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer

Tumor Clinical Trial

Official title:
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06455761
Other study ID # FirstAHFujian-68Ga-FAPI
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2025

Study information
Verified date June 2024
Source First Affiliated Hospital of Fujian Medical University
Contact Weibing Miao, MD
Phone +86-0591-87981618
Email miaoweibing@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 31, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 68Ga-DOTA-NI-FAPI04
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.
• 68Ga-FAPI/18F-FDG
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.

Locations
Country Name City State
China The First Affiliated Hospital of Fujian Medical University Fuzhou

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic value Sensitivity and Specificity of 68Ga-DOTA-NI-FAPI04 in Patients With Various Types of Cancer and comrare it with 68Ga-FAPI/18F-FDG PET/CT. through study completion, an average of 3 months
Secondary SUV of tumors Compare the SUV of tumors between 68Ga-DOTA-NI-FAPI04 PET/CT and 68Ga-FAPI/18F-FDG PET/CT. through study completion, an average of 3 months
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