Malignant Solid Tumors
Conditions
Brief summary
This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
Interventions
DRUG2.5-3.5mCi 64Cu-FAPI-XT117
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.
DRUG3.5-4.5mCi 64Cu-FAPI-XT117
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.
DRUG4.5-5.5mCi 64Cu-FAPI-XT117
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.
Sponsors
Sinotau Pharmaceutical Group
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. signed the informed consent * 2\. ≥18 years old * 3\. confirmed as malignant solid tumor by histopathology or clinical judgment * 4\. Patients will undergo 18F-FDG PET/CT examination
Exclusion criteria
* 1\. Known allergy to components of the investigational drug or its analogues * 2\. suspected to have a certain disease or condition that is not suitable for the study drug * 3\. Known pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 7 days following injection] | Evaluation of Adverse Events (AE) Using CTCAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic efficacy of 64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor | 2 months following injection | Accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV) |
| Change in 'treatment strategy questionnaire' | 2 months following 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. |
Other
| Measure | 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 |
Countries
China
Outcome results
None listed