68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 7, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 12, 2024
June 1, 2024
1 year
June 7, 2024
June 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
SUV of tumors
through study completion, an average of 3 months
Study Arms (2)
68Ga-DOTA-NI-FAPI04 PET/ CT
EXPERIMENTALIntravenous 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 PET/ CT
EXPERIMENTALIntravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18FFDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Various solid tumors with available histopathological findings; Signed informed consent.
You may not qualify if:
- pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Weibing Weibing, MD
First Affiliated Hospital of Fujian Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2024
First Posted
June 12, 2024
Study Start
April 1, 2024
Primary Completion
April 1, 2025
Study Completion
December 31, 2025
Last Updated
June 12, 2024
Record last verified: 2024-06