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Radiolabeled TSPO Targeted Molecular Probe in Glioma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07106008
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Nanjing First Hospital, Nanjing Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma (Any Grade) in the Brain

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Feng Wang

[email protected]

+8602552271491

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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