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Clinical Trial Summary

Subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and localized microcirculation in test animals with osteoporosis, fractures and after placement of bone substitute material with volume computed tomography (VCT) (animals only) and functional magnetic resonance imaging (MRI). Furthermore patients with multiple myeloma (MM) will be examined before and after placement of a commercially available bone substitute material. Osseous structures before intervention and structural changes of the bone especially at the junction of substitute material and residual bone will be documented. At this, the proposed techniques allow imaging of the dynamic healing processes in the living organism.

As next step patients with asymptomatic MM will be investigated with functional Imaging longitudinally to predict the occurence of osteolyses at time of Progression.

Hypothesis: Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI


Clinical Trial Description

In 157 patients with asymptomatic MM dynamic contrast-enhanced MRI (DCE-MRI) and diffusion weighted imaging (DWI) of the vertebral column will be performed every 6 months until progression and/ or occurance of first osteolysis.

In an experimental study, mice, rats and sheep with and without an osteoporotic phenotype will be imaged with VCT, morphologic MRI, DCE-MRI and DWI. Using these methods, bone structure, vascularization and cellularity will be assessed in control and osteoporotic animals. Furthermore, these morphological and functional imaging techniques will be applied before and after implantation of biomaterials in bone in order to characterize morphological and functional changes in bone upon implantation of these biomaterials. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01374412
Study type Observational
Source German Cancer Research Center
Contact Stefan Delorme, MD
Phone +49/6221/42-2563
Email s.delorme@dkfz.de
Status Recruiting
Phase
Start date July 2010
Completion date July 2022

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