68Ga-NI-FAPI PET/CT: First-in-human Study
1 other identifier
interventional
40
1 country
1
Brief Summary
68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.
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 Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
November 12, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 14, 2024
November 1, 2024
12 months
November 12, 2024
November 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
safety and tolerability
Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
up to 1 week
Secondary Outcomes (1)
Dosimetry of normal organs and tumors
From right after tracer injection to 150 minutes at post-injection
Other Outcomes (1)
Diagnostic value
through study completion, an average of 3 months
Study Arms (1)
68Ga-NI-FAPI PET/CT
EXPERIMENTALPET/CT imaging in patients with malignant tumors: each patient underwent a PET/CT scan after intravenous administration of 68Ga-NI-FAPI.
Interventions
Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-NI-FAPI.
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)
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Related Publications (1)
Zang J, Cheng H, Luo Y, Jin W, Lai Y, Zheng Q, Peng Y, Kung HF, Zhu L, Ke C, Liu C, Miao W. First-in-human study of a novel bifunctional PET tracer [68Ga]Ga-DOTA-NI-FAPI-04 targeting FAP and hypoxia. Eur J Nucl Med Mol Imaging. 2025 Oct 31. doi: 10.1007/s00259-025-07625-0. Online ahead of print.
PMID: 41168395DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Weibing Miao, MD
First Affiliated Hospital of Fujian Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2024
First Posted
November 14, 2024
Study Start
August 1, 2024
Primary Completion
July 31, 2025
Study Completion
December 31, 2025
Last Updated
November 14, 2024
Record last verified: 2024-11