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| Name | Class |
|---|---|
| Sinotau Pharmaceutical Group | INDUSTRY |
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This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga/64Cu-FAPI-XT117 PET/CT | Experimental | Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-4 mCi 68Ga/64Cu-FAPI-XT117 | Drug | 68Ga/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 2-4 mCi 68Ga/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 68Ga/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' |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruimin Wang | the First Medical Center, Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Medical Center, Chinese PLA General Hospital | Beijing | 100023 | China |
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| 4-6 mCi 68Ga/64Cu-FAPI-XT117 | Drug | 68Ga/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 4-6 mCi 68Ga/64Cu-FAPI-XT117 injection. |
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| 6-8 mCi 68Ga/64Cu-FAPI-XT117 | Drug | 68Ga/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 6-8 mCi 68Ga/64Cu-FAPI-XT117 injection. |
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Referring physicians were asked to complete and return 2 questionnaires. The first assessed the existing treatment plan for the patient without the information from 68Ga/64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 68Ga/64Cu-FAPI-XT PET images. |
| 2 months following injection |