Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis

ID: NCT01837589
Status: Completed
Phase: N/A
Start Date: January 01, 2012
First Submitted: November 15, 2012
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Hôpital Necker-Enfants Malades, Vaincre la Mucoviscidose
Location: France
Conditions: Cystic Fibrosis
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Study Description

Brief Summary

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

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.
Condition or disease Intervention/treatment Phase

Cystic Fibrosis

Other: QCT
Other Names
Quantitative Computed Tomodensitometry
Other: DXA
Other Names
Dual-emission X-ray
N/A

Tracking Information

First Submitted DateNovember 15, 2012
Last Update Posted DateFebruary 23, 2018
Actual Start DateJanuary 01, 2012
Actual Completion DateSeptember 01, 2016
Actual Primary Completion DateMay 01, 2015
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Evaluation of the mineralization with DXA(Dual-energy X-ray absorptiometry) as a Zscore of Bone mineral density and the Zscore of QCT (Quantitative computed tomography) [Time Frame: 1 day]

    Evaluation of the mineralization with DXA(Dual-energy X-ray absorptiometry) as a Zscore of Bone mineral density(reference population: same sex, same bone age) and the Zscore of QCT (Quantitative computed tomography) (reference population: same sex, same age)

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Evaluation of the prevalence of osteopenia in children and adult affected by cystic fibrosis. [Time Frame: 1 day]

  • Correlation of bone mineralization with nutritional status (BMI) [Time Frame: 1 day]

  • Correlation of bone mineralization with respiratory status (FEV % predicted) [Time Frame: 1 day]

  • Correlation of bone mineralization with Vitamine D (25(OH)vitD) [Time Frame: 1 day]

  • Correlation of bone mineralization with the amount of total inhaled and oral corticosteroids administered (total number of days of steroids according to diiferent modalities: inhaled, oral IV) [Time Frame: 1 day]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleQuantitative Computed Tomodensitometry in Patients With Cystic Fibrosis
Official TitleEvaluation of the Bone Mineralization by Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis : Validation Study
Brief Summary

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

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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
131
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Diagnostic
Conditions
Cystic Fibrosis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: QCT

Other Names
Quantitative Computed Tomodensitometry
Other: DXA

Other Names
Dual-emission X-ray
Study Groups/Cohorts
QCT and DXA
All the patients will have both QCT and DXA

Study Arms
Other QCT and DXA
All the patients will have both QCT and DXA
Other : QCT

Other QCT and DXA
All the patients will have both QCT and DXA
Other : DXA

Arm Intervention/Treatment
Other QCT and DXA
All the patients will have both QCT and DXA
Other : QCT
Other QCT and DXA
All the patients will have both QCT and DXA
Other : DXA

Recruitment Information

Recruitment Status:Completed
Enrollment131
Completion DateSeptember 01, 2016
Eligibility Criteria: 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
GenderAll
Age5 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
France

Administrative Information

NCT Number:NCT01837589
Other Study ID Numbers
N° ID RCB : 2009-A00292-55
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyIsabelle Sermet-Gaudelus, Hôpital Necker-Enfants Malades
Study Sponsor
Hôpital Necker-Enfants Malades
Collaborators
Vaincre la Mucoviscidose
Investigators
Principal Investigator
Isabelle Sermet-Gaudelus, Professor
Necker Hospital