Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging
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Purpose
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 non-malignant osteoporosis or multiple myeloma 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.
Hypothesis: Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI
| Condition |
|---|
|
Osteoporosis Multiple Myeloma Vertebral Fracture |
| Study Type: | Observational |
| Study Design: | 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 |
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2022 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
osteoporosis
patients with benign osteoporosis
|
Detailed Description:
In 30 patients with confirmed osteoporosis and vertebral fracture(s) dynamic contrast-enhanced MRI (DCE-MRI)and diffusion weighted imaging (DWI) of the vertebral column will be performed. Furthermore, 30 patients will be examined before and after insertion of foreign material as well as 2 weeks, 1 month and 4 months after surgery to investigate healing processes at the interface of bone and xenomaterial. New magnetic resonance imaging (MRI) sequences will be developed to improve the detection of osseous microstructure.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
patients with benign osteoporosis
Inclusion Criteria:
- benign osteoporosis
Exclusion Criteria:
- contra-indications for MRI
Contacts and Locations| Contact: Stefan Delorme, MD | +49/6221/42-2563 | s.delorme@dkfz.de |
| Germany | |
| German Cancer Research Center | Recruiting |
| Heidelberg, Germany, 69120 | |
| Study Chair: | Reinhard Schnettler, MD | Gießen University, Heidelberg |
More Information
No publications provided
| Responsible Party: | German Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT01374412 History of Changes |
| Other Study ID Numbers: | Transregio79B8 |
| Study First Received: | April 14, 2010 |
| Last Updated: | April 5, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Osteoporosis Spinal Fractures 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 Spinal Injuries Back Injuries Wounds and Injuries Fractures, Bone |
ClinicalTrials.gov processed this record on May 16, 2013