NCT03140644

Brief Summary

The goal of this study is to evaluate the diagnostic agreement between, on the one hand, ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan, to quantify lung parenchyma patterns in thoracic sarcoidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

7 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

April 25, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

May 16, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

4.4 years

First QC Date

April 25, 2017

Last Update Submit

May 16, 2023

Conditions

Sarcoidosis, Pulmonary

Keywords

thoracic sarcoidosisultra-low dose computed tomographyMagnetic resonance imaging using Ultrashort echo time

Outcome Measures

Primary Outcomes (1)

  • Percentage of fibrosis within the 2 lungs (reticulations with or without honeycombing) in standard CT and ULD CT to study diagnostic agreement between these techniques

    Day 0

Secondary Outcomes (24)

  • Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT

    Day 0

  • Percentage of consolidation within the 2 lungs in standard CT and ULD CT

    Day 0

  • Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT

    Day 0

  • Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI

    Day 0

  • Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI

    Day 0

  • +19 more secondary outcomes

Study Arms (1)

Patients with thoracic sarcoidosis

EXPERIMENTAL

Patients routinely followed-up for thoracic sarcoidosis with a CT scan indicated in the follow-up

Other: Patients with thoracic sarcoidosis

Interventions

Patients with thoracic sarcoidosisOTHER

Ultra-low dose CT scan and MRI with UTE

Patients with thoracic sarcoidosis

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 years or more
  • Diagnosed with thoracic sarcoidosis according to ATS/ERS/WASOG 1999 criteria, with stages 2, 3 or 4, or lung function significantly impaired
  • For whom a chest CT examination without contrast medium is indicated in the normal follow-up of the disease
  • covered by social security
  • having received information about the study and having given written informed consent

You may not qualify if:

  • Pregnant woman
  • Adult person unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CH de Bobigny, Hôpital Avicenne

Bobigny, France

Location

CHU de Brest

Brest, France

Location

CH de Lorient

Lorient, France

Location

CHU de Nantes

Nantes, France

Location

CHU Rennes

Rennes, France

Location

CH de Saint-Brieuc

Saint-Brieuc, France

Location

CH de Vannes

Vannes, France

Location

MeSH Terms

Conditions

Sarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesSarcoidosisLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

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

April 25, 2017

First Posted

May 4, 2017

Study Start

May 16, 2017

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

May 17, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)