This Protocol is a Sub-study Under the PPMI Program. It is a Longitudinal, Single-center Study to Assess the Performance of [18F]AV-133 Imaging Using High and Standard Resolution PET in Individuals Enrolled With Parkinson's Disease (PD) for up to 12 Months.
A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F]AV- 133 in Parkinson's Disease [Dual PET AV-133 in PD]
The study is a longitudinal, single-center study to assess progression of [18F]AV-133 imaging in PD participants. Participants will be followed for up to 12 months. Approximately 45 PD participants and 5 healthy control participants will be recruited from the ongoing PPMI Clinical 002 study. Participants will be comprehensively assessed at Baseline and follow up according to the Schedule of Activities. Participants will undergo PET imaging assessments with [18F]AV-133. After tracer injection, participants will be imaged on PET cameras at each imaging timepoint-one with the NX camera and one with a standard PET camera-in accordance with the Image Acquisition Protocol (IAP).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Lianne Ramia
- Número de teléfono: 203-590-5600
- Correo electrónico: LRamia1@indd.org
Copia de seguridad de contactos de estudio
- Nombre: Jessica Dimos
- Número de teléfono: 203-590-5600
- Correo electrónico: jdimos@indd.org
Ubicaciones de estudio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06517
- Reclutamiento
- Institute for Neurodegenerative Disorders
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Investigador principal:
- Neha Prakash, MBBS
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Contacto:
- Kristen Hagwell, RN
- Número de teléfono: 475-318-8259
- Correo electrónico: khagwell@xingimaging.com
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Contacto:
- Mackenzee George
- Correo electrónico: mgeorge@xingimaging.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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Participants over the age of 18 who are enrolled in the PPMI Clinical protocol with a diagnosis of Parkinson's disease (PD) or Healthy Control participants enrolled in the PPMI Clinical protocol.
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Able to provide informed consent.
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Male or Female (females must meet additional criteria specified below as applicable)
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Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of [18F]AV-133
- Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
- Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
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Females of childbearing potential must not be pregnant, breastfeeding or lactating.
- Includes a negative urine pregnancy test prior to injection of [18F]AV-133 on day of PET scan.
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Exclusion Criteria:
- Received any of the following medications that might interfere with [18F]AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline [18F]AV-133 injection.
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Plan de estudios
¿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 |
|---|---|
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Experimental: Parkinson's Disease & Healthy Controls
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This protocol is a sub-study under the PPMI Program. It is a longitudinal, single-center study to assess the performance of [18F]AV-133 imaging using high and standard resolution PET in individuals enrolled with Parkinson's disease (PD) for up to 12 months. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Comparison of tracer uptake between two cameras using Standardized Uptake Value Ratio (SUVR)
Periodo de tiempo: 12 months
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To compare longitudinal change in [18F]AV-133 PET SUVR in the striatum and other brain regions acquired with NeuroEXPLORER (NX) camera to that acquired with Siemens Biograph camera. |
12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ken Marek, MD, Institute for Neurodegenerative Disorders
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PPMI 033
Información sobre medicamentos y dispositivos, documentos del estudio
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