Radiolabeled TSPO Targeted Molecular Probe in Glioma

NCT07106008 | Not Yet Recruiting DMC

• 1 other identifier: KY20250624-08-KS-01
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• SUVmax of lesion uptake value

  Time Frame: 60min after administration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants were recruited through hospital electronic records and community health certers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Feng Wang

CONTACT

+8602552271491; fengwangcn@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07