Entire-body PET Scans for Multiple Sclerosis

Официальное название

Exploratory Study of Entire-body PET Scans for Multiple Sclerosis

Обзор

To evaluate whether an entire-body positron emission tomography (PET) scanner can be exploited to improve evaluation, monitoring and measurement of both peripheral and central demyelination in multiple sclerosis (MS) patients.

Подробное описание

To collect exploratory data using the most recent PET-CT scanners with their increased detection sensitivity and spatial resolution for the evaluation of F18-florbetapir radiopharmaceutical uptake in the nervous system of the entire body with special attention to correlation of radiotracer activity levels in the myelinated, demyelinated, or remyelinated white matter of multiple sclerosis (MS) patients compared to normal healthy subjects. The pilot study will be conducted on 20 participants as a clinical research trial of PET amyloid and myelin imaging with the primary objective of identifying possible differences in F18-florbetapir radiotracer activity for MS patients compared to normal healthy subjects, and the secondary objective of monitoring psychological health of those participants who elect to be informed of imaging results and who complete a panel of psychometric scales before and after imaging results disclosure.

Вмешательства

• Диагностический тест Entire-body PET-CT scans
  Entire-body PET-CT scans will be performed with state-of-the-art scanners with different manufacturers' models including Siemens Biograph Vision, United Imaging uEXPLORER and possibly other recently FDA-approved PET-CT scanners.
• Препарат Amyvid radiopharmaceutical
  Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants

Первичные конечные точки

• Entire-body PET imaging of demyelination of peripheral and central nervous system [Срок оценки: During 1 day single PET-CT scan]
• Psychometric questionnaire for monitoring psychological health [Срок оценки: Up to 90 days]

Критерии участия

Критерии включения

• Multiple sclerosis (MS) patients diagnosed by a credentialed neurologist experienced with care of multiple sclerosis patients.
• Normal healthy subjects.
• Willing and able to lie motionless on the PET-CT scanner bed for at least 10 minutes and up to 20 minutes for the duration of the PET-CT medical imaging scan.

Критерии исключения

• Any additional complicating medical illness other than MS including any other neuropsychiatric illness unrelated to MS diagnosed prior to the onset of initial symptoms of MS.
• Pregnancy or breast feeding.
• Diabetes or other metabolic-endocrine disorders.
• Any known concomitant acute infection.
• History of metastatic or locally invasive cancer.
• Recent surgery, chemotherapy or radiation therapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Brain Health Alliance — Ladera Ranch

Публикации

• Taswell C, Villemagne VL, Yates P, Shimada H, Leyton CE, Ballard KJ, Piguet O, Burrell JR, Hodges JR, Rowe CC. 18F-FDG PET Improves Diagnosis in Patients with Focal-Onset Dementias. J Nucl Med. 2015 Oct;56(10):1547-53. doi: 10.2967/jnumed.115.161067. Epub 2015 Aug 6. PMID 26251415

Идентификаторы

NCT: NCT04390009 · BHA-2020-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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