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

Guangzhou Medical University

Status and phase: Completed; Phase 1

Conditions: Malignant Solid Tumors

Treatments: Drug: 3.5-4.5mCi 64Cu-FAPI-XT117; Drug: 4.5-5.5mCi 64Cu-FAPI-XT117; Drug: 2.5-3.5mCi 64Cu-FAPI-XT117

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05930457

XT-XTR016-1-02

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

64Cu-FAPI-XT117 PET/CT

Experimental group

Treatment:

Drug: 3.5-4.5mCi 64Cu-FAPI-XT117

Drug: 2.5-3.5mCi 64Cu-FAPI-XT117

Drug: 4.5-5.5mCi 64Cu-FAPI-XT117