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

Phase 1

Completed

• Conditions: Malignant Solid Tumors
• Interventions: Drug: 2.5-3.5mCi 64Cu-FAPI-XT117; Drug: 3.5-4.5mCi 64Cu-FAPI-XT117; Drug: 4.5-5.5mCi 64Cu-FAPI-XT117

• Registration Number: NCT05930457
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-05
• Study Start: 2023-07-26
• Primary Completion: 2023-10-31
• Status Verified: 2023-12
• Study Completion: 2023-12-18
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
64Cu-FAPI-XT117 PET/CT	2.5-3.5mCi 64Cu-FAPI-XT117	-
64Cu-FAPI-XT117 PET/CT	3.5-4.5mCi 64Cu-FAPI-XT117	-
64Cu-FAPI-XT117 PET/CT	4.5-5.5mCi 64Cu-FAPI-XT117	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	7 days following injection]	Evaluation of Adverse Events (AE) Using CTCAE

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, China