Меню
Идёт набор NCT03492762

PET Imaging CCR2 in Lung Inflammation

Ранняя фаза I С лечением Lung Inflammation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cu-DOTA-ECL1i.
Кому может быть актуально
Состояния в реестре: Lung Inflammation. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The primary objective of this study is to assess the lung distribution of the Positron Emission Tomography (PET) imaging radiotracer Cu-DOTA-ECL1i, which binds to the specific population inflammatory cells, in patients with fibrotic lung diseases. This objective includes sub-studies to assess radiotracer distribution in the lung, the reproducibility of PET scans and the relationship of the scan to distribution of inflammatory cells in human lung tissue. The overall goal is to assess the potential of the radiotracer to track inflammatory cells in lung diseases.

Подробное описание

This is a single site, pilot Phase 0/1 clinical trial to establish the uptake of Cu-DOTA-ECL1i in additional patients with ILD fibrotic lung disease (n=60). Healthy volunteers without known pulmonary disease will be recruited as controls (N=5). All subjects will be recruited and undergo one dynamic PET/CT scan to characterize the lung uptake of Cu-DOTA-ECL1i. Among those with pulmonary fibrosis imaging, an arterial catheter will be placed for blood draws in n=10 subjects, an additional sub group of subjects (n=10) will undergo a second PET/CT within two months. A third subgroup of subjects (n=10) who undergo lung transplant will have analysis of CCR2+ cells in their explanted lungs.

Вмешательства

  • Препарат Cu-DOTA-ECL1i
    Radiolabeled probe called Cu-DOTA-ECL1i that recognizes CCR2 and propose to image CCR2 in the lung to ultimately guide diagnosis and therapy.

Первичные конечные точки

  • Change of uptake of Cu-DOTA-ECL1i to lung fibrosis [Срок оценки: Through study completion]
  • Change of Cu-DOTA-ECL1i as measured by Positron emission tomography (PET) imaging of lung Standard uptake value (SUV) and Distribution Volume Ratio (DVR) over two months [Срок оценки: Through study completion]
  • Determine rate of kinetics of Cu-DOTA-ECL1i [Срок оценки: Through study completion]
Вторичные конечные точки (1)
  • Determine relationship between Cu-DOTA-ECL1i lung tissue as seen by Positron emission tomography (PET) imaging and lung tissue showing C-C Motif Chemokine Receptor 2 (CCR2+) cells [Срок оценки: Through study completion]

Критерии участия

Критерии включения

  • Men or women 21 years of age or older who have never smoked or current smokers who smoked at least 10 cigarettes per day (1/2 pack) and have smoked at least 100 cigarettes (5 packs) over the past month.
  • Screening FEV1 and FVC > 80% of predicted
  • Capable of lying still and supine within the PET/CT and PET/MR scanner for \~1 hour and follow instructions for breathing protocol during the CT portion
  • No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year
  • No known history of cardiac, pulmonary, hepatic or renal disease or diabetes
  • No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions
  • Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol
  • BMI ≤ 35

Критерии исключения

  • Currently enrolled in another study using an investigational drug
  • Pregnancy (confirmed by urine pregnancy test)
  • Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes
  • Currently taking any prescription medications
  • Presence of an implanted device that is incompatible with CT or MRI scanning
  • Creatinine > 1.30 mg/dL, AST > 50 Units/L, ALT > 55 Units/L, or total bilirubin > 1.2 mg/dL

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
  • Washington University School of Medicine — St Louis

Публикации

  • Brody SL, Gunsten SP, Luehmann HP, Sultan DH, Hoelscher M, Heo GS, Pan J, Koenitzer JR, Lee EC, Huang T, Mpoy C, Guo S, Laforest R, Salter A, Russell TD, Shifren A, Combadiere C, Lavine KJ, Kreisel D, Humphreys BD, Rogers BE, Gierada DS, Byers DE, Gropler RJ, Chen DL, Atkinson JJ, Liu Y. Chemokine Receptor 2-targeted Molecular Imaging in Pulmonary Fibrosis. A Clinical Trial. Am J Respir Crit Care PMID 32673071

Идентификаторы

NCT: NCT03492762 · 20171192 · R01HL151685-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗