Nanjing First Hospital, Nanjing Medical University
Phase
Observational
Started
2025-09-01
Last updated
2025-08-06
Condition(s) studied
Alzheimer's Disease (AD)
Study summary
Evaluate the clinical application value of the novel radiolabeled TSPO-targeted molecular probe Gallium \[68Ga\]-DOTA-HK-011 in neuroinflammation imaging of Alzheimer's disease.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Volunteer for the trial, with the patient or their legal guardian signing the informed consent form.
* Volunteers are not limited by gender, and the age range is from 18 to 75 years old, including both ends.
* The patient is diagnosed with Alzheimer's disease (AD), supported by a positive amyloid PET scan.
* The patient has completed Tau PET scan.
Exclusion Criteria:
* Individuals with a history of allergy to drugs chemically or biologically similar to TSPO, a history of atopy, or currently suffering from allergic diseases.
* Use of anti-inflammatory drugs, including corticosteroids and immunosuppressants, within the past 14 days, which may interfere with the accuracy of inflammation imaging.
* Presence of other coexisting neurological diseases, such as stroke, Parkinson's disease, brain tumors, or mental disorders, including depressive disorder and schizophrenia.
* Severe cardiac, pulmonary, hepatic, or renal dysfunction, or uncontrolled systemic diseases; 5. Presence of metal implants contraindicated for MRI, including but not limited to cardiac pacemakers, artificial heart valves, and metal stents.
* Claustrophobia or inability to tolerate prolonged examinations.
* Pregnant women (defined as those with a positive urine pregnancy test) or breastfeeding women.
* Patients whose physical condition is unsuitable for radioactive tracer-based imaging examinations.
* Other circumstances deemed unsuitable for participation in the trial by the researcher.
Primary outcome measure(s)
SUVmax of lesion uptake value — 60min after administration
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital
Nanjing
Jingasu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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