Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis
NCT ID: NCT01837589
Last Updated: 2018-02-26
Study Results
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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COMPLETED
NA
131 participants
INTERVENTIONAL
2012-01-31
2016-09-30
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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QCT and DXA
All the patients will have both QCT and DXA
QCT
DXA
Interventions
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QCT
DXA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 with an infective exacerbation phase
5 Years
ALL
No
Sponsors
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Vaincre la Mucoviscidose
OTHER
Hôpital Necker-Enfants Malades
OTHER
Responsible Party
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Isabelle Sermet-Gaudelus
Professor
Principal Investigators
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Isabelle Sermet-Gaudelus, Professor
Role: PRINCIPAL_INVESTIGATOR
Necker Hospital
Locations
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Necker Hospital
Paris, , France
Countries
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Other Identifiers
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N° ID RCB : 2009-A00292-55
Identifier Type: -
Identifier Source: org_study_id
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