Radiolabeled TSPO Targeted Molecular Probe in Glioma

NCT ID: NCT07106008

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-08-31

Brief Summary

Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium [68Ga]-DOTA-HK-011 in inflammation imaging of glioma.

Conditions

Glioma (Any Grade) in the Brain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Voluntary subjects, patients, or their legal representatives must sign the informed consent form.
• There are no restrictions on the gender of volunteers; age must be between 18 and 75 years, inclusive.
• Other imaging examination methods (e.g., CT, MRI) show the presence of intracranial lesions.
• Patients with brain glioma who are scheduled for surgery or biopsy that will provide final pathological results.
• Patients must have a kidney GFR > 50 mL/min, ERPF > 280 mL/min, platelet count (PLT) > 75,000/μL, white blood cell count (WBC) > 3,000/μL, and alanine aminotransferase (ALT) and asparta.

Exclusion Criteria

• Individuals with a history of allergy to drugs with similar chemical or biological components to TSPO, a history of atopy, or currently suffering from allergic diseases.
• Individuals currently participating in other drug clinical studies, or who have previously participated in any drug (excluding vitamins and minerals) clinical studies.
• Individuals with other difficult-to-control clinical conditions, such as HIV infection, hepatitis C virus infection, active hepatitis B, other severe chronic infections, or serious mental, neurological, cardiovascular, respiratory, or other systemic diseases.
• Red blood cell count (RBC) < 4×10^12/L, white blood cell count (WBC) < 3×10^9/L, hemoglobin < 110 g/L, platelet count (PLT) < 75×10^9/L.
• Significant liver and kidney function abnormalities, glomerular filtration rate (GFR) < 50 ml/min.
• Tumor burden involving more than 50% of the affected organ, or significant spinal cord compression.
• Expected survival time less than six months, or having received chemotherapy within the past six months.
• Individuals with severe acute comorbidities or severe refractory mental disorders.
• Pregnant or breastfeeding women (pregnancy defined as a positive urine pregnancy test).
• Individuals whose physical condition is unsuitable for radioactive examination.
• Other circumstances deemed unsuitable for participation in the trial by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Feng Wang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Feng Wang

Role: CONTACT

fengwangcn@hotmail.com

+8602552271491

Other Identifiers

KY20250624-08-KS-01

Identifier Type: -

Identifier Source: org_study_id