Non-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 16
- 主要终点
- Sensitivity and specificity by visual analysis
研究概览
简要总结
Clinical study to demonstrate an at least equivalent performance of a new PET molecular Imaging radiopharmaceutical named [18F] LBT-999 in brain imaging compared to the SPECT reference method named [123I]-FP-CIT to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 35 to 80 (male or female)
- •Patients:
- •suffering from an essential tremor as defined by Elble's criteria from 2000 (excluding head tremor in decubitus and compatible with the study by the investigator)
- •or with Parkinson's disease as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB)
- •Patients with clinical symptoms dated more than 18 months ago
- •Women of childbearing potential who must have effective contraception at baseline and up to 30 days after the last administration of the radiopharmaceutical (investigational medicinal product or comparator)
- •Patients affiliated with or receiving a social security scheme
- •Patients who have been fully informed about the organization of the research and who have signed their informed consent
排除标准
- •Patients with atypical non-idiopathic Parkinson's syndrome (multi system atrophy, progressive supranuclear palsy, etc.)
- •Patients treated with deep brain stimulation
- •Patients with functional psychogenic movements
- •Patients with severe and progressive psychiatric disorders
- •Patients with disabling dyskinesia or essential tremor that are incompatible with imaging studies
- •Patients who have had an ionizing radiation examination on the brain within the last 3 months
- •Individuals with a contraindication to PET or SPECT imaging:
- •Patients with claustrophobia
- •Patients refusing to be informed in case of abnormalities detected during imaging tests
- •Patients treated with amphetamines, benzatropine, amfebutamone, cocaine, mazindol, methylphenidate, phentermine or sertraline
- •Individuals with a known allergy to the active substance or one of the excipients of the product under investigation or to the reference product or to or to thyroid treatment
- •Woman of childbearing age without effective contraception in the opinion of the investigator
- •Any other serious unstabilized chronic condition deemed incompatible with the study by the investigator
- •Patients unable to sign the informed consent
- •Patients participating in a protocol or in a period of exclusion from a protocol
- •Patients who received compensation of more than 6000 € in the last 12 months prior to enrollment in clinical studies
- •Patients in a period of exclusion from the national volunteer database during which they cannot participate in another clinical study
- •Patients not affiliated with a social security scheme
- •Patients refusing to participate
- •Individuals referred to in articles L. 1121-5 to L. 1121-8 and L1122-2 of the French Public Health Code
研究组 & 干预措施
SPECT and PET
[123I]-FP-CIT SPECT imaging procedure first, then [18F] LBT-999 PET Imaging procedure
干预措施: SPECT (Drug)
SPECT and PET
[123I]-FP-CIT SPECT imaging procedure first, then [18F] LBT-999 PET Imaging procedure
干预措施: PET (Drug)
PET and SPECT
[18F] LBT-999 PET imaging procedure first, then [123I]-FP-CIT SPECT imaging procedure
干预措施: SPECT (Drug)
PET and SPECT
[18F] LBT-999 PET imaging procedure first, then [123I]-FP-CIT SPECT imaging procedure
干预措施: PET (Drug)
结局指标
主要结局
Sensitivity and specificity by visual analysis
时间窗: The independent review committee will analyse the PET and SPECT images blindly. These analyses will be done by batch of 25 patients. Outcome will be assessed at the end of the study, an average of 2 years after first patient in.
Sensitivity and specificity of each imaging method on the diagnosis of normal or pathological examination on the visual analysis by 5 independent readers interpreting a minimum of 200 \[123I\]-FP/CIT SPECT per year, without knowing the clinical diagnosis.
次要结局
未报告次要终点