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Clinical trial

68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies

ID
Name
FirstAHFujian-FAP-CHX
Description
As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.
Trial arms
Trial start
2022-05-01
Estimated PCD
2025-05-01
Trial end
2025-05-01
Status
Recruiting
Phase
Early phase I
Treatment
68Ga-FAP-CHX
The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging
Arms:
Part I: safety, tolerability, biodistribution and dosimetry
68Ga-FAP-CHX
68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging； 68Ga-FAPI-04, the dose will be 1.8 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging； 18F-FDG, the dose will be 3.7 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging；
Arms:
Part II: diagnostic efficacy
Other names:
68Ga-FAPI-04, 18F-FDG
Size
50
Primary endpoint
Human biodistribution
From right after tracer injection to 2-hours post-injection
Human dosimetry
From right after tracer injection to 2-hours post-injection
Standard uptake value (SUV)
Up to 2 weeks
Lesion numbers
Up to 2weeks
the sensitivity of 68Ga-FAP-CHX PET/CT
Up to 2 weeks
the specificity of 68Ga-FAP-CHX PET/CT
Up to 2 weeks
the accuracy of 68Ga-FAP-CHX PET/CT
Up to 2 weeks
Eligibility criteria
Inclusion Criteria: * 18 years \< Age \< 75 years * Various solid tumors with available histopathological findings, and have not been treated surgically. * Signed informed consent. Exclusion Criteria: * patients with pregnancy * the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-09-21

1 organization

1 product

2 indications

Organization
First Affiliated Hospital of Fujian Medical University
Product
68Ga-FAP-CHX
Indication
Tumor
Indication
Positron Emission Tomography