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临床试验/NCT05476653
NCT05476653Unknown不适用

A Prospective Monocentric Study to Assess the Concordance of Lung MRI Compared to Chest CT Scan to Assess the Extent and Severity of Bronchial and Parenchymal Pulmonary Lesions in Adult Patients With Primary Immune Deficiency (PID): IRM vs SCANNER

Hopital Foch2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年11月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
Hopital Foch
入组人数
50
试验地点
2
主要终点
To assess the bronchial lesions

研究概览

简要总结

Currently, there is no official recommendations for the respiratory surveillance of patients with PID.However, it is recommended to perform a chest CT scan each 5 years or before any significant therapeutic change.

The methods of surveillance need to meet two contradictory imperatives:

  • monitor frequently enough not to diagnose with delay an aggravation of bronchiectasis or interstitial pneumonitis, an infectious complication by a slowly growing pathogen such as a non-tuberculous mycobacterium, or lymphoid proliferation.
  • do not expose these often young patients to significant irradiation by a considerable number of scans during their life. In addition, some patients with PID have increased radiosensitivity without a safe irradiation threshold having been determined.

To make thoses requirements effective, the solution is to combine radiological monitoring and absence of irradiation. Therefore, it makes sense to study whether chest scans can be replaced by MRI, non-irradiating imaging. But the question that needs to be answered is whether the information provided by the chest MRI is not inferior to that provided by the scanner.

The objective of this study is to assess the ability of MRI performed with ultrashort echo time to analyze the extent and severity of bronchial and pulmonary parenchymal lesions during the follow-up of patients with primary immunodeficiency, comparing them to those of the chest CT scan.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 or over
  • Adult patients with PID
  • Patients who have performed EFR (Functional Respiratory Tests) within 6 months
  • Patients who have signed a consent form
  • Patients affiliated with a Health Insurance plan.

排除标准

  • Pregnant woman
  • Contraindications to MRI:
  • Patients with magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants),
  • Patients with intraocular metal or in the brain (aneurysm clip),
  • Patients with prostheses in the thoracic position and contraindicated for MRI examination
  • Claustrophobic patients.
  • To be deprived of liberty or under guardianship.

结局指标

主要结局

To assess the bronchial lesions

时间窗: 6 montths

Analysis of the presence, the severity (cylindrical, varicose or cystic) and segmental distribution of bronchiectasis, 2. the presence and lobar distribution of hypoperfused pulmonary areas, and 3. the presence and lobar distribution of interstitial abnormality and pulmonary nodular lesions. Those three components will be independently identified by lung scanners and MRIs.

To assess the parenchymal lesions

时间窗: 6 montths

Analysis of the presence and lobar distribution of hypoperfused pulmonary areas

次要结局

  • To assess the MRI results versus the scanner results(6 months)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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