Glioma (Any Grade) in the BrainNCT07106008
Radiolabeled TSPO Targeted Molecular Probe in Glioma
An observational study of Glioma (Any Grade) in the Brain, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium [68Ga]-DOTA-HK-011 in inflammation imaging of glioma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioma (Any Grade) in the Brain
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants were recruited through hospital electronic records and community health certers
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Glioma
Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium [68Ga]-DOTA-HK-011 in inflammation imaging of glioma.
- Conditions
- Glioma (Any Grade) in the Brain
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax of lesion uptake value
Measured: Time Frame: 60min after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma (Any Grade) in the BrainStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106008
- Sponsor's protocol ID
- KY20250624-08-KS-01
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a Novel Radiolabeled Translocator Protein (TSPO) Targeted Small Molecular Probe in Neuroinflammation Imaging of Glioma
- ClinicalTrials.gov ID
- NCT07106008
- Acronym / sponsor ID
- KY20250624-08-KS-01
- Conditions
- Glioma (Any Grade) in the Brain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium [68Ga]-DOTA-HK-011 in inflammation imaging of glioma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited through hospital electronic records and community health certers
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SUVmax of lesion uptake value
Time frame: Time Frame: 60min after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma (Any Grade) in the Brain, run by Nanjing First Hospital, Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Wang (+8602552271491, fengwangcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax of lesion uptake value (time frame: Time Frame: 60min after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.