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Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging

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ClinicalTrials.gov Identifier: NCT01374412
Recruitment Status : Recruiting
First Posted : June 16, 2011
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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


Condition or disease
Osteoporosis Multiple Myeloma Vertebral Fracture

Detailed 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

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examination of Bone Defects and Microcirculation Using Volume Computed Tomography and Dynamic Contrast-enhanced Magnetic Resonance Imaging
Study Start Date : July 2010
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2022


Groups and Cohorts

Group/Cohort
osteoporosis
patients with benign osteoporosis


Outcome Measures

Primary Outcome Measures :
  1. Changes of microcirculation at the interface between bone and implanted xenomaterial in patients with osteoporosis or multiple myeloma [ Time Frame: before (baseline)and after intervention, in follow-up 2 weeks, 1 month, 4 months after intervention ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients with benign osteoporosis
Criteria

Inclusion Criteria:

  • benign osteoporosis

Exclusion Criteria:

  • contra-indications for MRI
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374412


Contacts
Contact: Stefan Delorme, MD +49/6221/42-2563 s.delorme@dkfz.de

Locations
Germany
German Cancer Research Center Recruiting
Heidelberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
Heidelberg University
Investigators
Study Chair: Reinhard Schnettler, MD Gießen University, Heidelberg
More Information

Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01374412     History of Changes
Other Study ID Numbers: Transregio79B8
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Back Injuries
Multiple Myeloma
Osteoporosis
Spinal Fractures
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Injuries
Wounds and Injuries
Fractures, Bone