First in Human Study of 68Ga/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 first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Detailed Description
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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.

Official Title
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First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant

Conditions
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Malignant Solid Tumors

Intervention / Treatment
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* Drug: 2-4 mCi 68Ga/64Cu-FAPI-XT117
* Drug: 4-6 mCi 68Ga/64Cu-FAPI-XT117
* Drug: 6-8 mCi 68Ga/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: 68Ga/64Cu-FAPI-XT117 PET/CT<br>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. | Drug: 2-4 mCi 68Ga/64Cu-FAPI-XT117<br>* 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.<br>Drug: 4-6 mCi 68Ga/64Cu-FAPI-XT117<br>* 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.<br>Drug: 6-8 mCi 68Ga/64Cu-FAPI-XT117<br>* 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.<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 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' | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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68Ga-FAPI 64Cu-FAPI