Nanjing First Hospital, Nanjing Medical University8 enrolled
Overview
Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium \[68Ga\]-DOTA-HK-011 in inflammation imaging of glioma.
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.
Outcomes
Primary Outcomes
SUVmax of lesion uptake value
Time frame: Time Frame: 60min after administration