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

Chinese PLA General Hospital14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Malignant Solid Tumors

Interventions

2-4 mCi 68Ga/64Cu-FAPI-XT117DRUG

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.

4-6 mCi 68Ga/64Cu-FAPI-XT117DRUG

6-8 mCi 68Ga/64Cu-FAPI-XT117DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

the First Medical Center, Chinese PLA General Hospital

Beijing, China

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Evaluation of Adverse Events (AE) Using CTCAE

Time frame: 7 days following injection

Secondary Outcomes

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)

Time frame: 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.

Time frame: 2 months following injection

Data from ClinicalTrials.gov

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