CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01397435
NCT01397435N/ACompleted

Quantification of Bone Marrow Involvement in Gaucher Disease With Proton MR Spectroscopy, Correlation With Bone Marrow Burden Score, Genotype and Disease Severity Score for Pediatric Patients

Children's Hospital of Philadelphia·observational·Posted Jul 19, 2011·Updated Feb 4, 2015

In Brief

An observational study for Gaucher. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The bone status in Gaucher disease is very difficult to monitor precisely in children. This is a major problem because lack of optimal treatment, especially enzyme replacement, may cause irreversible severe bone damage that will impact an affected person's life. Currently, there are qualitative (subjective) methods, such as Magnetic resonance Imaging (MRI), to gauge the response to treatment. A quantitative (objective) measurement of Gaucher cell presence and activity in bone marrow could help with more precise and accurate monitoring of bone marrow disease in patients both treated and not (yet) being treated with enzyme replacement. The investigators will evaluate the efficacy of Magnetic Resonance Spectroscopy (MRS) as a quantitative assessment of bone marrow involvement in Children with Gaucher, and examine how this result correlates with semiquantitative MRI scales and overall disease severity.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGaucher
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2011
Enrollment StartJul 1, 2011
Primary CompletionDec 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.0 years ago