NCT03357562

Brief Summary

The aim of the study is to assess the diagnostic sensitivity of MRI to detect changes in Helbich-Bhalla scoring over time in patients with cystic fibrosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

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

November 15, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 5, 2018

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

6.8 years

First QC Date

November 15, 2017

Last Update Submit

March 17, 2025

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosisCTMRIradiation dosecontrast agent

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of MRI to detect lung changes

    deterioration or improvement measured by the Helbich-Bhalla scoring with CT as gold standard

    Month 36

Secondary Outcomes (11)

  • Sensitivity of MRI to Helbich-Bhalla scoring change

    Month 0 and Month 36

  • CT / MR concordance

    Month 0 and Month 36

  • Sensitivity of the 3D-UTE MR sequence

    Month 0 and Month 36

  • Imaging quality of the 3D-UTE MR

    Month 0, Month 12, Month 24 and Month 36

  • Correlation between a specific Helbich-Bhalla MR score and the amplitude of change

    Month 0 and Month 36

  • +6 more secondary outcomes

Study Arms (1)

lung MRI

EXPERIMENTAL

lung MRI without contrast injection

Device: lung MRI

Interventions

lung MRIDEVICE

lung MRI without contrast injection

lung MRI

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • male or female children (age ≥ 8 y.o) and adult patient with a diagnosis of cystic fibrosis provided by genetic and swear test older than 8 years. Subgroups of patients will be defined according to:
  • age: younger or older 18y.o. We expect around 50% in different subgroups. In case of, we reach 50% in one of these groups, patient recruitment will continue for both groups until the expected number of patients in the study is reached.
  • brand name of magnet: Siemens, General Electric or Philips
  • new drugs use: association Ivacaftor/lumicaftor (OrkambiØ) or Ivacaftor only (Kalydeco Ø) ) We expect approximately 20% to 50% of patients treated
  • Informed consent provided to the patient or/and to legal representative for adults and to parents for the children
  • Patient concerned by articles L 1121-6, L 1121-7, and L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent) if the expected benefit for such persons justifies the foreseeable risk incurred

You may not qualify if:

  • patients without any social security or health insurance
  • pregnant women
  • MRI contraindications:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University Hospital of Bordeaux

Bordeaux, 33000, France

Location

University Hospital of Bordeaux

Bordeaux, 33076, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHRU de Grenoble

Grenoble, 38043, France

Location

CHRU de Lille

Lille, 59000, France

Location

Hopital Nord

Marseille, 13385, France

Location

Hopital Universitaire de la Timone

Marseille, 13385, France

Location

Fondation Lenval

Nice, 06200, France

Location

Hôpital Armand-Trousseau

Paris, 75012, France

Location

Hôpital Necker Enfant Malades

Paris, 75015, France

Location

CHRU Bretonneau-Tours

Tours, 37044, France

Location

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 Design

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

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 30, 2017

Study Start

May 5, 2018

Primary Completion

March 6, 2025

Study Completion

March 6, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Locations

FR(11)