Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by German Cancer Research Center
Heidelberg University
Information provided by (Responsible Party):
German Cancer Research Center Identifier:
First received: April 14, 2010
Last updated: April 22, 2014
Last verified: March 2014

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

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

Resource links provided by NLM:

Further study details as provided by German Cancer Research Center:

Primary Outcome Measures:
  • 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)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients with benign osteoporosis


Inclusion Criteria:

  • benign osteoporosis

Exclusion Criteria:

  • contra-indications for MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01374412

Contact: Stefan Delorme, MD +49/6221/42-2563

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

No publications provided

Responsible Party: German Cancer Research Center Identifier: NCT01374412     History of Changes
Other Study ID Numbers: Transregio79B8
Study First Received: April 14, 2010
Last Updated: April 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices processed this record on March 03, 2015