Advanced Imaging for Pulmonary Fibrosis
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: [68Ga]CBP8, Gadoterate Meglumine.
- Кому может быть актуально
- Состояния в реестре: Pulmonary Fibrosis. Базовые параметры: 18 лет — 80 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 →
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Обзор
The purpose of this study is to determine if measurements of active collagen deposition using \[68Ga\]CBP8 positron emission tomography (PET) and tissue injury using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can predict an individual patient's pace of disease progression in non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) and identify which individuals will develop progressive pulmonary fibrosis.
Подробное описание
60 participants with non-idiopathic pulmonary fibrosis interstitial lung disease (non-IPF ILD) on stable dose immunosuppression treatment will be enrolled. Participants will undergo combined \[68Ga\]CBP8 positron emission tomography (PET) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at baseline. The investigators will compare the ability of PET and MRI measurements performed over the whole lung and within regions of interest to identify participants who subsequently develop progressive pulmonary fibrosis as determined by changes in pulmonary function testing, quantitative fibrosis on high-resolution computed tomography, and respiratory symptoms over 24 months. The investigators will also test whether combining the PET and MRI measurements results in more accurate prediction of progression than either modality alone.
Вмешательства
- Препарат [68Ga]CBP8
Participants will receive a single intravenous injection of up to 350 MBq of \[68Ga\]CBP8 - Препарат Gadoterate Meglumine
Participants will receive a single intravenous injection of 0.05 mmol/kg gadoterate meglumine during DCE-MRI
Первичные конечные точки
- Development of progressive pulmonary fibrosis [Срок оценки: Up to 24 months]
Вторичные конечные точки (3)
- Decline of forced vital capacity (FVC) ≥ 5% from baseline [Срок оценки: Up to 24 months]
- Decline of forced vital capacity (FVC) ≥10% from baseline [Срок оценки: Up to 24 months]
- Decline of diffusing capacity for carbon monoxide (DLCO) ≥15% from baseline [Срок оценки: Up to 24 months]
Критерии участия
Критерии включения
- Age 18-80 with a diagnosis of chronic hypersensitivity pneumonitis, connective tissue-associated ILD (due to rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease), or undifferentiated ILD.
- On stable dose immunosuppression treatment (with prednisone, mycophenolate mofetil, mycophenolate sodium, and/or rituximab) for at least 3 months.
- Pulmonary fibrosis, defined as honeycombing, traction bronchiectasis, or reticular opacities on HRCT performed within 1 year to or at Visit 1.
- FVC of >/= 45% and DLCO >/= 25% predicted on PFTs performed at Visit 1.
Критерии исключения
- Current or prior exposure to FDA approved anti-fibrotic therapy.
- Extent of emphysema greater than extent of fibrosis.
- Pregnancy or plans to become pregnant at baseline or during follow-up.
- Contraindications to MRI.
- Contraindications to receiving gadolinium-based contrast agents.
- Research-related radiation exposure exceeds 50 mSv in the prior year.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min (only for individuals with a history of chronic kidney disease).
- Clinically significant PH defined by use of pulmonary vasodilatory therapy.
- Respiratory infection within the prior 6 weeks.
- Smoking of any kind within the prior 6 months.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
США · 1 центр
- Massachusetts General Hospital — Boston
Публикации
- Izquierdo-Garcia D, Desogere P, Fur ML, Shuvaev S, Zhou IY, Ramsay I, Lanuti M, Catalano OA, Catana C, Caravan P, Montesi SB. Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. J Nucl Med. 2023 May;64(5):775-781. doi: 10.2967/jnumed.122.264530. Epub 2022 Dec 8. PMID 37116909
- Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available. PMID 31161770
- Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696. PMID 28381537
Идентификаторы
NCT: NCT06532071 · 2024P001746