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Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism

2 de octubre de 2018 actualizado por: Yi-Hsin Weng, Chang Gung Memorial Hospital

Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism by 18F-DTBZ PET

This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients with ET, and 10 patients with DT.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

Study duration is expected to be completed in a period of 4 year. This study is a uncontrolled, open-label, non-randomized, parallel, and cross-sectional study. Total 130 subjects, including 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, 20 patients with VaP, 20 patients with ET, and 10 patients with DT, will be enrolled.

Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study, as one screening visit, one imaging visit, and one safety evaluation visit.

Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

Tipo de estudio

Intervencionista

Inscripción (Actual)

72

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Taoyuan, Taiwán, 333
        • Chang Gung Memory Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

20 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Twenty subjects with a diagnosis of PD whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled "UK Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of PD" (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  2. Twenty subjects with a diagnosis of MSA whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the Consensus diagnostic criteria of "possible" or "probable" MSA14 (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  3. Twenty subjects with a diagnosis of PSP whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the NINDS-SPSP clinical criteria for the diagnosis of PSP " as possible" or "probable" PSP55 (Appendix III).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  4. Twenty subjects with a diagnosis of CBS whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the"Mayo Clinic proposed criteria for the diagnosis for corticobasal syndrome"56 (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  5. Twenty subjects with a diagnosis of VaP whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the clinical diagnostic criteria of vascular parkinsonism. (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  6. Twenty subjects with a diagnosis of ET whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "The Consensus Criteria of the MDS on Essential Tremor"30. (Appendix I).

    iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

  7. Ten subjects with a diagnosis of DT whom must:

    i. Male or female patients, age range 20~80. ii. Patients should be fulfilled the "The Consensus Criteria of the MDS on Dystonic Tremor"30. (Appendix I).

iii. Patients who provide a written informed consent prior to study entry. If the patient is incapable of informed consent, the caregiver may consent on behalf of the patient (the patient must still confirm assent).

Exclusion Criteria:

  1. Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding..
  2. Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.

    i. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.

    ii. Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.

  3. History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
  4. History or presence of QTc prolongation.
  5. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
  6. Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus and encephalomalacia, will be excluded. Mild cortical atrophy and non-specific white matter changes will be allowed.
  7. Patients who have the evidence of secondary parkinsonism or other neurodegenerative diseases, such as spinocerellar atrophy (SCA), Wilson's disease, hydrocephalus , serious head injury and definite history of neurotoxin exposure, are excluded.
  8. History of allergy to radioligands that contain 18F isotope.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 18F-DTBZ for Parkinson's Disease and parkinsonism

This study will compare the brain uptake of 18F- DTBZ in 20 patients with PD, 20 patients with MSA, 20 patients with PSP, 20 patients with CBS, and 20 patients with VaP, 20 patients with ET, and 10 patients with DT.

Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping, each subject will have 3 visits in this study. Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-DTBZ immediately prior to imaging.

The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Analyzing the differences of monoaminergic degeneration between each group by comparing the SUVR of 18F- DTBZ measured by the VOIs methods in each brain region.
Periodo de tiempo: 4 years

During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-DTBZ immediately prior to imaging.

The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG.

4 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Statistical parametrical mapping will be performed to compare the early-phase and delayed-phase imaging of 18F- DTBZ PET in each group.
Periodo de tiempo: 4 years
Statistical parametrical mapping (SPM) will be performed to compare the early-phase (cerebral perfusion) and delayed-phase (monoaminergic system) imaging of 18F- DTBZ PET in each group. The capability of 18F- DTBZ PET imaging as an imaging biomarker in differentiating PD and PM will be also investigated.
4 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2013

Finalización primaria (Actual)

31 de julio de 2018

Finalización del estudio (Actual)

31 de julio de 2018

Fechas de registro del estudio

Enviado por primera vez

7 de febrero de 2014

Primero enviado que cumplió con los criterios de control de calidad

7 de febrero de 2014

Publicado por primera vez (Estimar)

11 de febrero de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de octubre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

2 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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