Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma

Chinese PLA General Hospital (301 Hospital)

Status and phase: Enrolling; Early Phase 1

Conditions: Clear Cell Renal Cell Carcinoma and Glioblastoma

Treatments: Drug: 68Ga-XT771

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07067905

S2025-149-02

Details and patient eligibility

About

A prospective, open-label, phase 1 study. This clinical trial aims to evaluate the diagnostic value of 68Ga-XT771, a CAIX/CAXII protein-specific probe, in PET/CT imaging for patients with clear cell renal cell carcinoma and glioblastoma. Safety, tolerability, and biodistribution characteristics of 68Ga-XT771 will also be assessed.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. signed the informed consent 2. ≥18 years old 3. Patients with glioblastoma or clear cell renal cell carcinoma

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)

---

15 participants in 1 patient group

Participant Group

Experimental group

Description:

Experimental: 68Ga-XT771 Subjects with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-XT771followed by PET imaging. The subjects will also receive a 18F-FDG PET/CT or 68Ga-DPI-4552 scan within a four-week period. Pathologically confirmed glioblastoma subjects will receive intravenous administration of the CAIX/CAXII-targeted probe 68Ga-XT771, followed by PET imaging. Additionally, 11C-METHIONINE (11C-MET) PET scanning will be performed within a 4-week window Drug: 68Ga-XT771 68Ga-XT771 is injected intravenously with a dose of 4-8 mCi

Treatment:

Drug: 68Ga-XT771