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NCT Number: NCT07106008

Radiolabeled TSPO Targeted Molecular Probe in Glioma

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. SUVmax of lesion uptake value

    Time frame: Time Frame: 60min after administration

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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