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| Name | Class |
|---|---|
| Sinotau Pharmaceutical Group | INDUSTRY |
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This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 64Cu-FAPI-XT117 PET/CT | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5-3.5mCi 64Cu-FAPI-XT117 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Evaluation of Adverse Events (AE) Using CTCAE | 7 days following injection] |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 months following injection |
| Change in 'treatment strategy questionnaire' |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of the 64Cu-FAPI-XT and optimal scanning specifications for future studies | From first dose of imaging study drug through two hours post dose | |
| Determine impact of administered dose of 64Cu-FAPI-XT on image quality | From first dose of imaging study drug through two hours post dose |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China |
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| 3.5-4.5mCi 64Cu-FAPI-XT117 | Drug | 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. |
|
| 4.5-5.5mCi 64Cu-FAPI-XT117 | Drug | 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. |
|
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. |
| 2 months following injection |