Collagen-targeted PET Imaging for Early Interstitial Lung Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Degree of uptake of [68Ga]CBP8
研究概览
简要总结
The goal of this study is to investigate the ability of [68Ga]CBP8 to detect collagen deposition in early interstitial lung disease.
详细描述
[68Ga]CBP8, is a PET imaging probe which selectively binds collagen type I. Collagen deposition is a pivotal event in the development of pulmonary fibrosis. [68Ga]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles. [68Ga]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis and response to treatment. In addition, [68Ga]CBP8 can detect increased collagen in the lungs of patients with idiopathic pulmonary fibrosis.
The goals of this study are:
- To determine whether collagen deposition as assessed by [68Ga]CBP8-PET MRI can detect increased collagen deposition in early interstitial lung disease and
- if the degree of [68Ga]CBP8 uptake predicts subsequent disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1: First degree relatives of a family member with pulmonary fibrosis (n=8)
- •Age greater than 40 years
- •Have the ability to give written informed consent
- •First degree relative of a family member with pulmonary fibrosis
- •No known history of interstitial lung disease
- •No tobacco use within the prior 6 months.
- •Group 2: Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) (n=22)
- •Age greater than 40 years
- •Have the ability to give written informed consent
- •ILAs or early ILD (defined by presence of reticular markings and / or traction bronchiectasis but absence of a definite UIP pattern)
- •No tobacco use within the prior 6 months.
排除标准
- •Electrical implants such as cardiac pacemaker or perfusion pump
- •Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
- •Historical eGFR of less than 30 mL/min/1.73 m2
- •Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate)
- •Claustrophobic reactions
- •Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months)
- •Unable to lie comfortably on a bed inside the MR-PET
- •BMI > 33 (limit of the PET-MRI table)
- •Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures)
- •Pneumonia or other acute respiratory illness within 6 weeks of study entry
- •Parenchymal lung disease except for ILD/ILAs or emphysema
- •Acute exacerbation of ILD within the prior 6 months
- •VATS within the prior 6 months
- •Prior radiation therapy to the thorax
- •Known allergy to gadolinium.
研究组 & 干预措施
First degree relatives of a family member with pulmonary fibrosis
First degree relatives of a family member with pulmonary fibrosis will receive [68Ga]CBP8 and undergo PET-MRI.
干预措施: [68Ga]CBP8 (Drug)
Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)
Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive [68Ga]CBP8 and undergo PET-MRI.
干预措施: [68Ga]CBP8 (Drug)
Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD)
Subjects with interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) will receive [68Ga]CBP8 and undergo PET-MRI.
干预措施: Dotarem (Drug)
First degree relatives of a family member with pulmonary fibrosis
First degree relatives of a family member with pulmonary fibrosis will receive [68Ga]CBP8 and undergo PET-MRI.
干预措施: Dotarem (Drug)
结局指标
主要结局
Degree of uptake of [68Ga]CBP8
时间窗: 24 months
The degree of uptake of \[68Ga\]CBP8 in the lungs will be compared between groups and associations with disease severity and progression will be determined.
次要结局
- Rate of MRI contrast arrival, Kwashin, in the lungs(24 months)
- Peak enhancement of MRI contrast in the lungs(24 months)
- Rate of MRI contrast clearance, Kwashout, in the lungs(24 months)
研究者
Sydney Butler Montesi
Principal Investigator
Massachusetts General Hospital