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

NCT07067905 | Recruiting Early Phase 1

• 1 other identifier: S2025-149-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Clear Cell Renal Cell Carcinoma and Glioblastoma

Keywords

clear cell renal cell carcinoma; glioblastoma; CAIX; CAXII; XT771

Outcome Measures

Primary Outcomes (1)

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

  Evaluation of Adverse Events (AE) Using CTCAE

  7 days following injection

Study Arms (1)

Participant Group

EXPERIMENTAL

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

Drug: 68Ga-XT771

Interventions

68Ga-XT771 DRUG

68Ga-XT771 is injected intravenously with a dose of 4-8 mCi

Participant Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Sinotau Pharmaceutical Group: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Glioblastoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Central Study Contacts

Ruimin Wang

CONTACT

+8613501151740; wrm@yeah.net

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chinses PLA General Hospital, nuclear medicine department

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: June 27, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

CN (1)