NCT04644471

Brief Summary

The purpose of this study is to compare the performances of ultra-low dose computed tomography (CT) and lung magnetic resonance imaging (MRI) for morphological assessment of cystic fibrosis-related lung disease and to compare their performances to conventional low dose CT

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

October 5, 2020

Last Update Submit

February 11, 2026

Conditions

Cystic Fibrosis

Keywords

Magnetic resonance imagingMultidetector computed tomography

Outcome Measures

Primary Outcomes (1)

  • Reproducibility of visual score between imaging modalities

    Reproducibility disease severity measured by the Helbich scoring system with conventional CT as gold standard

    1 day

Secondary Outcomes (3)

  • Intra and interobserver reproducibility of visual scores

    1 day

  • Correlation between visual scores and pulmonary function

    1 day

  • Correlation between air trapping at MRI and pulmonary function test

    1 day

Interventions

CT scannerDIAGNOSTIC_TEST

1 conventional low dose inspiratory acquisition and 1 ultra-low-dose inspiratory acquisition

Lung MRIDIAGNOSTIC_TEST

3 UTE sequences (free breathing, inspiratory and expiratory) and 1 T2 sequence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 year-old
  • Diagnosis of cystic fibrosis provided by genetic and swear test
  • Chest CT acquisition performed as part of the standard follow-up
  • Patient with social security or health insurance
  • Informed consent

You may not qualify if:

  • MRI contraindication
  • Orthopnea
  • Inability to hold breath for 17 seconds
  • No spirometry planned the same day
  • Lung transplant patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cochin hospital

Paris, 75014, France

Location

Related Publications (4)

  • Dournes G, Grodzki D, Macey J, Girodet PO, Fayon M, Chateil JF, Montaudon M, Berger P, Laurent F. Quiet Submillimeter MR Imaging of the Lung Is Feasible with a PETRA Sequence at 1.5 T. Radiology. 2015 Jul;276(1):258-65. doi: 10.1148/radiol.15141655. Epub 2015 Mar 13.

    PMID: 25768672BACKGROUND

  • Dournes G, Menut F, Macey J, Fayon M, Chateil JF, Salel M, Corneloup O, Montaudon M, Berger P, Laurent F. Lung morphology assessment of cystic fibrosis using MRI with ultra-short echo time at submillimeter spatial resolution. Eur Radiol. 2016 Nov;26(11):3811-3820. doi: 10.1007/s00330-016-4218-5. Epub 2016 Feb 2.

    PMID: 26843010BACKGROUND

  • Chassagnon G, Martin C, Ben Hassen W, Freche G, Bennani S, Morel B, Revel MP. High-resolution lung MRI with Ultrashort-TE: 1.5 or 3 Tesla? Magn Reson Imaging. 2019 Sep;61:97-103. doi: 10.1016/j.mri.2019.04.015. Epub 2019 Apr 30.

    PMID: 31051201BACKGROUND

  • Chassagnon G, Martin C, Marini R, Vakalopolou M, Regent A, Mouthon L, Paragios N, Revel MP. Use of Elastic Registration in Pulmonary MRI for the Assessment of Pulmonary Fibrosis in Patients with Systemic Sclerosis. Radiology. 2019 May;291(2):487-492. doi: 10.1148/radiol.2019182099. Epub 2019 Mar 5.

    PMID: 30835186BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Marie-Pierre REVEL, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2020

First Posted

November 25, 2020

Study Start

August 5, 2021

Primary Completion

July 25, 2024

Study Completion

July 25, 2024

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)