Assessment of Cystic Fibrosis Lung Involvement With UTE Pulse Sequences

NCT02449785 | Completed

• 1 other identifier: CHUBX2014/11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive assessment of lung involvement is a crucial issue for the follow-up of cystic fibrosis patients. Currently, CT is the method of reference to evaluate and quantify the lung morphological changes in cystic fibrosis adults but it remains a radiation-based technique. MRI with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. The investigators' objective is to evaluate cystic fibrosis lung involvement using CT and MRI-UTE, and to test the agreement between both techniques.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; MRI; UTE; CT; Exacerbation; Quality of life; Pulmonary function

Outcome Measures

Primary Outcomes (1)

• Agreement between MRI and CT for scoring lung involvement in cystic fibrosis

  MRI and CT evaluation of lung lesions quantification in cystic fibrosis will be assessed by 2 blind radiologists. Agreement between both evaluation will be assessed during statistical analyses after study completion.

  During MRI and CT, Day one

Secondary Outcomes (6)

• Cystic fibrosis lesions scoring extracted from CT and MR images

  During MRI and CT, Day one

• MRI cystic fibrosis reproductibility scoring over the time

  During MRI, Day one

• Correlation between MRI cystic fibrosis scoring and PFT indexes

  Day one

• Correlation between MRI cystic fibrosis scoring and exacerbation number

  12 month after Day one

• Correlation between MRI cystic fibrosis scoring and quality of life

  Day one and 12 month after Day one

Study Arms (1)

Cystic fibrosis adults

EXPERIMENTAL

Device: MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens); Device: CT measurements of lung morphological changes in cystic fibrosis

Interventions

MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens) DEVICE

Cystic fibrosis adults

CT measurements of lung morphological changes in cystic fibrosis DEVICE

Cystic fibrosis adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cystic fibrosis adults
• written informed consent

You may not qualify if:

• Subjects without any social security or health insurance
• Pregnancy
• MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital Bordeaux

Pessac, France

Location

Related Publications (1)

• Benlala I, Point S, Leung C, Berger P, Woods JC, Raherison C, Laurent F, Macey J, Dournes G. Volumetric quantification of lung MR signal intensities using ultrashort TE as an automated score in cystic fibrosis. Eur Radiol. 2020 Oct;30(10):5479-5488. doi: 10.1007/s00330-020-06910-w. Epub 2020 May 15.

  PMID: 32415586 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

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

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 20, 2015
• Study Start: September 30, 2015
• Primary Completion: September 6, 2016
• Study Completion: September 6, 2017
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

FR (1)