Radiolabeled TSPO Targeted Molecular Probe in Glioma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Glioma (Any Grade) in the Brain. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Glioma
Overview
Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium \[68Ga\]-DOTA-HK-011 in inflammation imaging of glioma.
Primary outcome measures
- SUVmax of lesion uptake value [Time frame: Time Frame: 60min after administration]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07106008 · KY20250624-08-KS-01