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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01374412
Other study ID # Transregio79B8
Secondary ID
Status Recruiting
Phase N/A
First received April 14, 2010
Last updated December 6, 2016
Start date July 2010
Est. completion date July 2022

Study information

Verified date December 2016
Source German Cancer Research Center
Contact Stefan Delorme, MD
Phone +49/6221/42-2563
Email s.delorme@dkfz.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2022
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- benign osteoporosis

Exclusion Criteria:

- contra-indications for MRI

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Germany German Cancer Research Center Heidelberg

Sponsors (2)

Lead Sponsor Collaborator
German Cancer Research Center Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of microcirculation at the interface between bone and implanted xenomaterial in patients with osteoporosis or multiple myeloma This is a study within a multicenter multiproject frame. Development of bone-stabilizing implant material designed to stimulate the formation and regeneration of physiologically structured bone after vertebral collapse will be investigated. The subproject examins the interaction between host and graft. Hypothesis: Implanted materials will function as a framework for osteogenesis, and successful integration of the foreign material goes along with transient increase in microcirculation. Amplitude A and exchange rate constant kep of DCE-MRI will be measured to detect changes in microcirculation. before (baseline)and after intervention, in follow-up 2 weeks, 1 month, 4 months after intervention No
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