Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis

NCT ID: NCT01837589

Last Updated: 2018-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-09-30

Brief Summary

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The purpose of this study is to conduct a comparative study for the study of bone mineralization evaluated with Quantitative computed tomodensitometry (QCT) compared to the reference technique, Dual-emission X-ray absorptiometry (DXA).

Detailed Description

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Patients with cystic fibrosis can have a deficit in bone mineralization. This is particularly well described in adults. However, in the pediatric population the results are more heterogeneous. The evaluation is hindered by difficulties in standardization of DXA interpretation.

This measurement depends from the mass and size of the bone as well as the mass of soft tissue covering the bone area. These two characteristics, intrinsic to the measurement, pose a significant problem of interpretations in children because a change in bone density may reflect both a change in bone mineral content or changes related to growth, for example, the increase in bone size or volume of soft tissue covering the bone of interest.

Quantitative computed tomography (QCT) provides a direct measure of bone mineralization densitometry volume. It quantifies bone mineral content in relation to the volume of the bone, in reference to an external phantom. This method therefore overcomes the size size.

This technique can be considered without an additional radiation exposure to patients during a lung CT because it is usual that lumbar vertebrae are included in the measurement window because of pulmonary hyperinflation. This exam would be ideal for patients with Cystic fibrosis.

All patients have these two evaluations during their routine management. This study compare study on the bone mineralization evaluated by (QCT) compared to the reference technique by (DXA) for the patient affected by cystic fibrosis for each patient.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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QCT and DXA

All the patients will have both QCT and DXA

Group Type OTHER

QCT

Intervention Type OTHER

DXA

Intervention Type OTHER

Interventions

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QCT

Intervention Type OTHER

DXA

Intervention Type OTHER

Other Intervention Names

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Quantitative Computed Tomodensitometry Dual-emission X-ray

Eligibility Criteria

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Inclusion Criteria

* Patients affected by cystic fibrosis
* Aged over 5 years
* Patients whose clinical condition warrants an indication of chest CT in relation to the criteria of the french consensus conference on Cystic fibrosis in May 2002 (Palace of the Luxembourg).
* Patients whose clinical condition warrants an indication of DXA examination in accordance with French recommendations (Consensus of the Working Group "bone mineralization and cystic fibrosis" In children, the examination is recommended for ages 8 every 2 years if the Z-score is greater than - 1, every year if the Z-score is less than - 1.. In adults, the exam is recommended every 5 years if the T-score is greater than\> - 1, every 2 years if it is between -1 and - 2; annually if less than - 2.)
* Patient does not exhibit a phase of bronchial exacerbation
* Collection of non-opposition of the patient
* Patient affiliated to social security

Exclusion Criteria

* Patient transplanted
* Patient with an infective exacerbation phase
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vaincre la Mucoviscidose

OTHER

Sponsor Role collaborator

Hôpital Necker-Enfants Malades

OTHER

Sponsor Role lead

Responsible Party

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Isabelle Sermet-Gaudelus

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isabelle Sermet-Gaudelus, Professor

Role: PRINCIPAL_INVESTIGATOR

Necker Hospital

Locations

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Necker Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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N° ID RCB : 2009-A00292-55

Identifier Type: -

Identifier Source: org_study_id

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