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A clinical study evaluating the safety and imaging performance of the fluorine-18 labeled GPR52-targeted imaging probe 18F-PB324 in humans

A clinical study evaluating the safety and imaging performance of the fluorine-18 labeled GPR52-targeted imaging probe 18F-PB324 in major depression disorder patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125872
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depression disorder

Interventions

Healthy Control:18F-PB324 PET/MR scan
Major Depression Disordor:18F-PB324 PET/MR scan

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Inclusion Criteria for Participants With Depression (n = 6): (1) Patients with a clinically confirmed diagnosis of depression: patients who meet the DSM-5 diagnostic criteria for Major Depressive Disorder (MDD); (2) Patients with depression characterized primarily by anhedonia, who also meet the following conditions: clinical assessment identifies "markedly diminished interest or pleasure" as a core symptom according to DSM-5, and the total score on the Snaith-Hamilton Pleasure Scale (SHAPS; 14 items in total) is >= 20; (3) Current depressive episode lasting >= 4 weeks and = 18 years; (7) 20 = 18 years; (4) 20 <= BMI <= 25.

Exclusion criteria

Exclusion criteria: 1. Exclusion Criteria for Participants With Depression: (1) Individuals with comorbid psychiatric disorders such as schizophrenia, bipolar disorder, obsessive-compulsive disorder, or substance use disorder, or with central nervous system diseases; (2) Individuals with other severe physical illnesses that may affect imaging results, prevent the participant from tolerating the examination, or lead to other difficult-to-control clinical problems, such as a history of head trauma or surgery, HIV infection, hepatitis C virus infection, active hepatitis B, other severe chronic infections, or severe neurological, cardiovascular, respiratory, or other systemic diseases; (3) Individuals with abnormal liver function, based on laboratory tests at our hospital: alanine aminotransferase (ALT) > 29 U/L, aspartate aminotransferase (AST) > 31 U/L, total bilirubin (TBIL) > 20.5 µmol/L, or albumin (ALB) 76 µmol/L, or estimated glomerular filtration rate (eGFR) 29 U/L, aspartate aminotransferase (AST) > 31 U/L, total bilirubin (TBIL) > 20.5 µmol/L, or albumin (ALB) 76 µmol/L, or estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m^2; (4) Individuals with abnormal hematopoietic function, based on laboratory tests at our hospital: white blood cell count < 4.1 x 10^9/L, neutrophil count < 1.8 x 10^9/L, platelet count < 150 x 10^9/L, red blood cell count < 4.1 x 10^9/L, or hemoglobin < 114 g/L; (5) Individuals

Design outcomes

Primary

MeasureTime frame
PET/MR imaging parameters;Hemodynamic parameters;Adverse events related to 18F-PB324 PET/MR imaging.;

Secondary

MeasureTime frame
adiometric dosimetry parameters.;

Countries

China

Contacts

Public ContactWei Zhang

West China Hospital of Sichuan University

weizhanghx@163.com+86 189 8060 1010

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026