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Diagnostic Value of [18F]-fluorodopa(dopa) in Parkinsonian Syndromes

Diagnostic Value of [18F]-fluorodopa(dopa) in Parkinsonian Syndromes

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115340
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Parkinson's Disease, Multiple System Atrophy, and Progressive Supranuclear Palsy

Interventions

Patients with Parkinson's Disease:None
Patients with Multiple System Atrophy:None
Patients with Progressive Supranuclear Palsy:None
Healthy controls:None

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Healthy controls (1) Aged between 45 and 75 years, regardless of gender. (2) Cognitively normal as determined by the investigator via cognitive testing, with a score of 0 on Part III of the Unified Parkinson's Disease Rating Scale (UPDRS). (3) Confirmed by the investigator to have no neurological diseases, major chronic illnesses, malignancies, or acute infectious diseases. (4) No family history of neurological disorders related to movement or cognitive impairment. (5) Capable of understanding and providing written informed consent prior to any assessments. (6) Female participants must provide medical documentation of surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal status for more than one year. Those of childbearing potential must agree to use contraception for 3 months following the study initiation. (7) Male participants must agree to use contraception and refrain from sperm donation for 3 months following the study initiation. (8) Willing and able to comply with all study procedures. 2. PD Patients (1) Aged between 45 and 75 years, regardless of gender. Must meet the diagnostic criteria for Parkinson's Disease (as per the International Parkinson and Movement Disorder Society's 2015 diagnostic guidelines). (2) Diagnosis must be independently confirmed by two neurology specialists from Huashan Hospital's Department of Neurology specializing in movement disorders. Any diagnostic disagreements will be resolved by discussion within Huashan Hospital's Movement Disorders Specialty Group, with subsequent a-synuclein-related pathological examination conducted as recommended by diagnostic standards for necessary confirmation or revision. (3) Brain MRI findings support the PD diagnosis and show no evidence of other neurological diseases. (4) Medications for improving symptoms of neurodegenerative movement disorders must be maintained at a stable dose for at least 30 days prior to study initiation. (5) Participants may be accompanied by a caregiver during the study if necessary. (6) Participants or their legal guardians must be capable of understanding and providing written informed consent before any assessments. (7) Female participants must provide medical documentation of surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal status for more than one year. Those of childbearing potential must agree to use contraception for 3 months following the study initiation. (8) Male participants must agree to use contraception and refrain from sperm donation for 3 months following the study initiation. (9) Willing and able to comply with all study procedures. 3. MSA Patients (1) Aged between 45 and 75 years, regardless of gender. (2) Must meet the diagnostic criteria for Multiple System Atrophy (as per the International Parkinson and Movement Disorder Society's third diagnostic criteria). Diagnosis must be independently confirmed by two neurology specialists from Huashan Hospital's Department of Neurology specializing in movement disorders. Any diagnostic disagreements will be resolved by discussion within Huashan Hospital's Movement Disorders Specialty Group, with subsequent a-synuclein-related pathological examination conducted as recommended by diagnostic standards for necessary confirmation or revision. (3) Brain MRI findings support the MSA diagnosis and show no evidence of other neurological diseases. (4) Medications for improving sympt

Exclusion criteria

Exclusion criteria: 1. Healthy controls (1) Individuals with neurodegenerative diseases, or severe neurological disorders other than the condition under study, or severe diseases of the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory systems, immunodeficiency, or other major illnesses. (2) Individuals who have received ionizing radiation exposure from sources outside the scope of this experiment for other clinical or research purposes within the past year, resulting in an annual cumulative effective dose exceeding 50 mSv. (3) History of substance abuse or alcohol dependence. (4) Women who are pregnant or breastfeeding. (5) Poor venous access, unable to tolerate repeated venipuncture. (6) Administration of (investigational drugs or devices with unclear efficacy or safety profiles) within 1 month prior to the study. (7) Any condition that, in the opinion of the investigators, may pose a risk or potential risk to the participant during any part of this trial. 2. PD Patients (1) Individuals with severe neurological disorders other than Parkinson's disease, or severe diseases of the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory systems, immunodeficiency, or other major illnesses. (2) Individuals who have received ionizing radiation exposure from sources outside the scope of this experiment for other clinical or research purposes within the past year, resulting in an annual cumulative effective dose exceeding 50 mSv. (3) History of substance abuse or alcohol dependence. (4) Women who are pregnant or breastfeeding. (5) Poor venous access, unable to tolerate repeated venipuncture. (6) Administration of (investigational drugs or devices with unclear efficacy or safety profiles) within 1 month prior to the study. (7) Any condition that, in the opinion of the investigators, may pose a risk or potential risk to the participant during any part of this trial. 3. MSA Patients (1) Individuals with severe neurological disorders other than Multiple System Atrophy, or severe diseases of the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory systems, immunodeficiency, or other major illnesses. (2) Individuals who have received ionizing radiation exposure from sources outside the scope of this experiment for other clinical or research purposes within the past year, resulting in an annual cumulative effective dose exceeding 50 mSv. (3) History of substance abuse or alcohol dependence. (4) Women who are pregnant or breastfeeding. (5) Poor venous access, unable to tolerate repeated venipuncture. (6) Administration of (investigational drugs or devices with unclear efficacy or safety profiles) within 1 month prior to the study. (7) Any condition that, in the opinion of the investigators, may pose a risk or potential risk to the participant during any part of this trial. 4. PSP Patients (1) Individuals with severe neurological disorders other than Progressive Supranuclear Palsy, or severe diseases of the gastrointestinal, cardiovascular, hepatic, renal, hematological, oncological, endocrine, respiratory systems, immunodeficiency, or other major illnesses. (2) Individuals who have received ionizing radiation exposure from sources outside the scope of this experiment for other clinical or research purposes within the past year, resulting in an annual cumulative effective dose exceeding 50 mSv. (3) History of substance abuse or

Design outcomes

Primary

MeasureTime frame
Typical imaging patterns of [18F]-DOPA PET in PD, MSA, PSP, and healthy controls;

Secondary

MeasureTime frame
Correlation between [18F]-DOPA PET imaging features and clinical severity (e.g., Hoehn-Yahr stage, UPDRS scores);Movemenavt Disorder Society-sponsored Unified Parkinson’s Disease Rating Scale;

Countries

China

Contacts

Public ContactLiu Fengtao

Huashan Hospital, Fudan University

liufengtao@fudan.edu.cn+86 139 1760 4896

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026