68Ga-FAPI-Biotin PET/CT in Patients With Various Types of Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
As a new dual targeting PET radiotracer, 68Ga-FAPI-Biotin is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-Biotin in patients with various types of cancer and compared them with the results of 68Ga-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAPI.
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 Mar 2024
Typical duration for early_phase_1
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
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
December 13, 2024
CompletedFirst Posted
Study publicly available on registry
December 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedDecember 18, 2024
December 1, 2024
2.3 years
December 13, 2024
December 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic value
Sensitivity and Specificity of 68Ga-FAPI-Biotin in Patients With Various Types of Cancer and compare 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-FAPI-Biotin PET/ CT
EXPERIMENTALIntravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI-Biotin. Tracer of 68Ga-FAPI-Biotin will be used to detect tumors by PET/CT.
68Ga-FAPI/18F-FDG PET/CT
ACTIVE COMPARATORIntravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg18F-FDG. Tracer 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-FAPI-Biotin. Tracer doses of 68Ga-FAPI-Biotin 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)
First Affiliated Hospital of Fujian Medical University
Fuzhou, China
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
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2024
First Posted
December 18, 2024
Study Start
March 1, 2024
Primary Completion
June 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 18, 2024
Record last verified: 2024-12