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Radiolabeled TSPO Targeted Molecular Probe in Glioma

Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Glioma

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07106008
Enrollment
8
Registered
2025-08-06
Start date
2025-09-01
Completion date
2026-08-31
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma (Any Grade) in the Brain

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.

Interventions

None listed

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
SUVmax of lesion uptake valueTime Frame: 60min after administration

Contacts

Primary ContactFeng Wang
fengwangcn@hotmail.com+8602552271491

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026