Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

Study Overview
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Brief Summary
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This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Official Title
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Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

Conditions
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Malignant Solid Tumors

Intervention / Treatment
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* Drug: 2.5-3.5mCi 64Cu-FAPI-XT117
* Drug: 3.5-4.5mCi 64Cu-FAPI-XT117
* Drug: 4.5-5.5mCi 64Cu-FAPI-XT117


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 64Cu-FAPI-XT117 PET/CT<br> | Drug: 2.5-3.5mCi 64Cu-FAPI-XT117<br>* 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.<br>Drug: 3.5-4.5mCi 64Cu-FAPI-XT117<br>* 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.<br>Drug: 4.5-5.5mCi 64Cu-FAPI-XT117<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Evaluation of Adverse Events (AE) Using CTCAE | 7 days following injection] | 

Secondary Outcome Measures

| Outcome Measure | 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' | 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 |