Positron Emission Tomography (PET) Imaging of Neuroinflammation in Patients With Neurological Dysfunction After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Infection

Официальное название

PET Imaging of Neuroinflammation in Patients With Neurological Dysfunction After SARS-CoV-2 Infection

Обзор

This clinical imaging study will use the small molecule translocator protein (TSPO) ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The brain uptake of DPA-714 will be contrasted with healthy subjects.

Вмешательства

• Препарат DPA-714 PET/MRI
  DPA-714 PET/MRI

Первичные конечные точки

• Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers [Срок оценки: Injection/scan date to clinical follow-up. (Usually within 6 weeks)]

Критерии участия

Критерии включения

• 18 to 65 years of age
• Healthy volunteer OR Clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)
• High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
• PASC participants must have been previously infected with SARS-CoV-2. Their neurological symptoms must have been present for at least four weeks prior to the enrollment.
• Healthy control participants must have no neurological symptoms

Критерии исключения

• Contraindication to MRI
• Pregnancy
• Lactation
• Individuals who are unable to participate in the imaging portion due to severity of their medical condition
• Chronic infectious disease (e.g. HIV, HCV)
• Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
• Diagnosis of cancer, including leukemia
• Blood or blood clotting disorder
• Except for individuals with Multiple Sclerosis (MS), a diagnosis of autoimmune disease is exclusionary
• Positive urine β-hCG test day of procedure or a serum human chorionic gonadotropin (hCG) test within 48 hours prior to the administration of \[18F\]DPA-714.11.

11Currently enrolled in a clinical trial utilizing experimental therapies. 12. Currently taking experimental therapies 13. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.

The following exclusionary criteria apply only to PASC patients and healthy controls:

14\. Self-reported history of moderate or severe traumatic brain injury 15. Self-reported history of whiplash injury 16. Self-reported history of Inflammatory bowel disease (IBD). (Individuals with Irritable Bowel Syndrome (IBS) and no signs of inflammation will be allowed to participate.) 17. The following blood test results (at screening) will be exclusionary: 18. Rheumatoid Factor (RF) => 14 IntUnits/mL, 19. Anti-nuclear antibody (ANA) > 1:80, 20. Erythrocyte sedimentation rate (ESR) > 60mm/hour, 21.High sensitivity C-reactive protein (hsCRP) > 10mg/L, 22. Complete blood count (CBC) results indicating acute infection, anemia, or other condition, 23. T3, T4, or thyroid-stimulating hormone (TSH) levels out of normal range, 24. Fasting glucose > 100 mg/dL, 25. Blood chemistry results indicating organ damage or other serious medical condition 26. Use of illicit substances within the past 6 months 27. Self-reported diagnosis of Type I or Type II diabetes 28. Healthy controls must not regularly take over-the-counter anti-inflammatory medication, analgesics (except aspirin), or sleep medication

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• UAB — Birmingham

Идентификаторы

NCT: NCT05656105 · IRB-300010479 R22-209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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