Malignant Solid Tumors
Conditions
Keywords
68Ga-FAPI 64Cu-FAPI
Brief summary
This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
Detailed description
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.
Interventions
DRUG2-4 mCi 68Ga/64Cu-FAPI-XT117
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.
DRUG4-6 mCi 68Ga/64Cu-FAPI-XT117
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.
DRUG6-8 mCi 68Ga/64Cu-FAPI-XT117
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.
Sponsors
Sinotau Pharmaceutical Group
Chinese PLA General Hospital
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 68Ga/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 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. |
Countries
China
Outcome results
None listed