Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07105956

Radiolabeled TSPO Targeted Molecular Probe in Alzheimer's Disease.

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital

Nanjing, Jingasu, 210006, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. SUVmax of lesion uptake value

    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 Alzheimer's Disease.

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.

Published trials that share one or more normalized conditions with this study.