Tumor Clinical Trial
Official title:
68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | May 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Fujian Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Human biodistribution | reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I) | From right after tracer injection to 2-hours post-injection | |
Primary | Human dosimetry | radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the OLINDA software. | From right after tracer injection to 2-hours post-injection | |
Primary | Standard uptake value (SUV) | Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG | Up to 2 weeks | |
Primary | Lesion numbers | Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG | Up to 2weeks | |
Primary | the sensitivity of 68Ga-FAP-CHX PET/CT | compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated. | Up to 2 weeks | |
Primary | the specificity of 68Ga-FAP-CHX PET/CT | compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated. | Up to 2 weeks | |
Primary | the accuracy of 68Ga-FAP-CHX PET/CT | compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated. | Up to 2 weeks | |
Secondary | Count of participants with treatment emergent adverse events | The frequency and severity of treatment emergent adverse events following 68Ga-FAP-CHX injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | Up to 3 days | |
Secondary | Expression ability of 68Ga-FAP-CHX in different types of tumors | Differentiation of SUVmax in different tumors | Up to 3 days |
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