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

August 3, 2022 updated by: German Cancer Research Center

Examination of Bone Defects and Microcirculation Using Volume Computed Tomography and Dynamic Contrast-enhanced Magnetic Resonance Imaging

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).

In vivo imaging by means of functional MRI and VCT is carried out in osteoporotic rats, both after the induction of fracture as well as after the placement of bone substitute material.

Furthermore, patients with asymptomatic MM are investigated with functional MR-Imaging (Dynamic Contrast Enhancement- MRI and Intravoxel incoherent motion (IVIM)-imaging) longitudinally to predict the occurrence of osteolysis and the time to progression regarding SLIM-CRAB-Criteria (Rajkumar et al., Lancet Oncology, 2014).

Hypothesis:

  1. Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI
  2. Functional MRI has prognostic value regarding occurrence of osteolysis and progression to MM regarding SLIM-CRAB-Criteria

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

In an experimental study, rat models were used for imaging studies employing MRI (morphological, DCE- and DWI) and VCT. Mice were not used for imaging purposes due to the small size. Rats were shown to be of optimal size for small imaging studies.

144 patients with (suspected) asymptomatic MM were recruited for dynamic contrast-enhanced MRI (DCE-MRI) and diffusion weighted imaging (DWI) of the vertebral column as well as whole-body MRI using T1tse and STIR images every 6 months until progression and/ or occurrence of first osteolysis.

While during planning and initiation of this prospective trial MM was defined by CRAB-criteria only, in 2014 the SLIM-CRAB-criteria were proposed by the International Myeloma Working Group (Rajkumar et al., Lancet Oncology, 2014) with the goal to treat patients before development of osteolysis or other CRAB-criteria. These criteria were consequently introduced in clinical practice at our institution during the observation period of this study, which affects both inclusion and progression criteria of this study. In order to obtain a conclusive cohort with homogenous inclusion and progression criteria, SLIM-CRAB-criteria where retrospectively applied to restage all patients regarding inclusion and progression to MM defined by SLIM-CRAB-criteria.

Study Type

Observational

Enrollment (Actual)

144

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • German Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with benign osteoporosis

Description

Inclusion Criteria:

  • benign osteoporosis

Exclusion Criteria:

  • contra-indications for MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
osteoporosis
patients with benign osteoporosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of microcirculation at the interface between bone and implanted xenomaterial in animal models.
Time Frame: VCT and MRI 2-6 weeks after xenomaterial implantation
Characteristics of the microcirculation within and in the close proximity of the bone defect in early stages and during the healing process after the placement of bone substitute materials in animal models. Correlation of functional imaging parameters derived from DCE-MRI, DWI and VCT assessed in the bone defect area with the later stage healing processes in the affected bone.
VCT and MRI 2-6 weeks after xenomaterial implantation
Progression to multiple myeloma defined by SLIM-CRAB-Criteria (Rajkumar, Lancet Oncology, 2014)
Time Frame: At inclusion in the study and in repetitive follow up every 6 months until progression requiring therapy, until contraindications for MRI are present, until patient wishes to leave the study or until death (assessed up to 20 years)
In the study part applying functional imaging in asymptomatic myeloma patients, progression to Multiple Myeloma defined by SLIM-CRAB-Criteria is the primary outcome measure
At inclusion in the study and in repetitive follow up every 6 months until progression requiring therapy, until contraindications for MRI are present, until patient wishes to leave the study or until death (assessed up to 20 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of osteolysis
Time Frame: At inclusion in the study and in repetitive follow up every 6 months until progression requiring therapy, until contraindications for MRI are present, until patient wishes to leave the study or until death (assessed up to 20 years)
In the study part applying functional imaging in asymptomatic myeloma patients, occurrence of osteolysis in x-ray / CT imaging is the secondary outcome measure.
At inclusion in the study and in repetitive follow up every 6 months until progression requiring therapy, until contraindications for MRI are present, until patient wishes to leave the study or until death (assessed up to 20 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Cancer Research Center

Collaborators

Heidelberg University

Investigators

  • Study Chair: Reinhard Schnettler, MD, Gießen University, Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

June 15, 2011

First Posted (ESTIMATE)

June 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Transregio79B8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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