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临床试验/NCT06057714
NCT06057714
招募中
不适用

Quantitation and Spatial Registration of Airways Dysfunction With Dynamic 19F MRI in Cystic Fibrosis

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 30 人2021年1月20日

概览

阶段
不适用
干预措施
19F MRI
疾病 / 适应症
Cystic Fibrosis
发起方
University of North Carolina, Chapel Hill
入组人数
30
试验地点
1
主要终点
Change in Ventilation Defect Parameter (VDP) over 14 days
状态
招募中
最后更新
2个月前

概览

简要总结

The purpose of this study is to look at lung ventilation in people with cystic fibrosis over time (1 year) using magnetic resonance imaging (MRI) with an inhaled contrast gas, and compare these measures to lung function assessed by spirometry and multiple breath nitrogen washout. This study also looks at how these measures change in response to a pulmonary exacerbation and treatment (if applicable). Over the span of a year, participants would be asked to complete 3-5 visits to the University of North Carolina at Chapel Hill (UNC). with each lasting up to 4 hours. If participants do not have a pulmonary exacerbation during the year they would be asked to complete 3 visits (one at enrollment, a second roughly 2 weeks later, and the third approximately a year later). If participants do experience a CF pulmonary exacerbation they would complete 5 visits (Visit 1, Visit 2, two exacerbation visits with one before treatment and the other after, and Visit 3 at one year after Visit 1). Only one exacerbation per participant will be tracked. Participants are eligible for this study if they are 18 years old or older, have Cystic Fibrosis (CF) with mild lung disease (FEV1 >/= 60%), and can undergo an MRI. There are no known benefits for participating in this study.

注册库
clinicaltrials.gov
开始日期
2021年1月20日
结束日期
2026年6月1日
最后更新
2个月前
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • Subjects must be ≥18 years of age
  • Non-smokers (\<10 pack/year history and no active smoking in the past year)
  • Diagnosis of cystic fibrosis via standard sweat chloride/phenotypic features/genotyping
  • No use of supplemental oxygen
  • Stable lung function (within 10% of personal best in the last 6 months) with no pulmonary exacerbations in the past 4 weeks and baseline FEV1≥60% of predicted
  • Evidence of a personally signed and dated consent indicating that the subject has been informed of all pertinent aspects of the trial
  • Subjects must be willing and able to comply with scheduled visits and other trial procedures

排除标准

  • Subjects presenting with any of the following will not be included in the trial:
  • Active or past smokers or vapers with less than 1 year since quitting or \>10 pack-year smoking history
  • Unable to undergo a 3.0-Tesla MRI exam of the lungs and chest because of contraindications including
  • Occupation (past or present) of machinist, welder, or grinder;
  • Injury to the eye involving a metallic object
  • Injury to the body by a metallic object (bullet, bullet ball, shrapnel)
  • Presence of a cardiac pacemaker or defibrillator
  • Presence of aneurysm clips
  • Presence of carotid artery vascular clamp
  • Presence of neurostimulator

研究组 & 干预措施

All Participants

All subjects to receive inhaled perfluoropropane via standard Douglas bag at every visit (3-5 visits). They will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant). Not to exceed 30 liters inhaled at each visit as this is the max capacity of our Douglas bag.

干预措施: 19F MRI

结局指标

主要结局

Change in Ventilation Defect Parameter (VDP) over 14 days

时间窗: Day 1 to Day 14

VDP measured at Day 1 and Day 14, expressed as a percentage of total lung volume

Change in VDP over 365 days

时间窗: Day 1 to Day 365 (+/- 30 days)

Average of VDP measured at Day 1 and Day 14; subtracted from VDP at Day 365, expressed as a percentage of total lung volume

Change in FLVlongtau2 occurring with a protocol-defined CF pulmonary exacerbation

时间窗: Day 1 to Day 365 (+/- 30 days)

Difference in FLVlongtau2 between baseline and exacerbation visit 1, expressed as a percentage of total lung volume.

Change in FLVlongtau2 over 14 days

时间窗: Day 1 to Day 14

FLVlongtau2 measured at Day 1 and Day 14, expressed as a percentage of total lung volume

Change in FLVlongtau2 over 365 days

时间窗: Day 1 to Day 365 (+/- 30 days)

Average of FLVlongtau2 measured at Day 1 and Day 14; subtracted from FLVlongtau2 at Day 365, expressed as a percentage of total lung volume

Change in VDP occurring with a protocol-defined CF pulmonary exacerbation

时间窗: Day 1 to Day 365 (+/- 30 days)

Difference in VDP between baseline and exacerbation visit 1, expressed as a percentage of total lung volume.

次要结局

  • Correlation of MRI severity score with FLVlongtau2 at baseline.(Day 1 to Day 14)
  • Change in MRI severity score over 365 days(Day 1 to Day 365 (+/- 30 days))
  • Correlation of MRI severity score with VDP at baseline.(Day 1 to Day 14)

研究点 (1)

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