This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 2.5-3.5mCi 64Cu-FAPI-XT117 injection.
64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 3.5-4.5mCi 64Cu-FAPI-XT117 injection.
64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 4.5-5.5mCi 64Cu-FAPI-XT117 injection.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Evaluation of Adverse Events (AE) Using CTCAE
Time frame: 7 days following injection]
The diagnostic efficacy of 64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor
Accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV)
Time frame: 2 months following injection
Change in 'treatment strategy questionnaire'
Referring physicians were asked to complete and return 2 questionnaires. The first assessed the existing treatment plan for the patient without the information from 64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 64Cu-FAPI-XT PET images.
Time frame: 2 months following injection
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