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

NCT ID: NCT01374412

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2024-01-01

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).

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

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.

Conditions

Osteoporosis; Multiple Myeloma; Vertebral Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

osteoporosis

patients with benign osteoporosis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• benign osteoporosis

Exclusion Criteria

• contra-indications for MRI

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: collaborator

German Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reinhard Schnettler, MD

Role: STUDY_CHAIR

Gießen University, Heidelberg

Locations

German Cancer Research Center

Heidelberg, , Germany

Countries

Germany

References

Rajkumar SV, Dimopoulos MA, Palumbo A, Blade J, Merlini G, Mateos MV, Kumar S, Hillengass J, Kastritis E, Richardson P, Landgren O, Paiva B, Dispenzieri A, Weiss B, LeLeu X, Zweegman S, Lonial S, Rosinol L, Zamagni E, Jagannath S, Sezer O, Kristinsson SY, Caers J, Usmani SZ, Lahuerta JJ, Johnsen HE, Beksac M, Cavo M, Goldschmidt H, Terpos E, Kyle RA, Anderson KC, Durie BG, Miguel JF. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014 Nov;15(12):e538-48. doi: 10.1016/S1470-2045(14)70442-5. Epub 2014 Oct 26.

Reference Type: BACKGROUND

PMID: 25439696 (View on PubMed)

Wennmann M, Klein A, Bauer F, Chmelik J, Grozinger M, Uhlenbrock C, Lochner J, Nonnenmacher T, Rotkopf LT, Sauer S, Hielscher T, Gotz M, Floca RO, Neher P, Bonekamp D, Hillengass J, Kleesiek J, Weinhold N, Weber TF, Goldschmidt H, Delorme S, Maier-Hein K, Schlemmer HP. Combining Deep Learning and Radiomics for Automated, Objective, Comprehensive Bone Marrow Characterization From Whole-Body MRI: A Multicentric Feasibility Study. Invest Radiol. 2022 Nov 1;57(11):752-763. doi: 10.1097/RLI.0000000000000891. Epub 2022 May 27.

Reference Type: DERIVED

PMID: 35640004 (View on PubMed)

Wennmann M, Goldschmidt H, Mosebach J, Hielscher T, Bauerle T, Komljenovic D, McCarthy PL, Merz M, Schlemmer HP, Raab MS, Sauer S, Delorme S, Hillengass J. Whole-body magnetic resonance imaging plus serological follow-up for early identification of progression in smouldering myeloma patients to prevent development of end-organ damage. Br J Haematol. 2022 Oct;199(1):65-75. doi: 10.1111/bjh.18232. Epub 2022 May 24.

Reference Type: DERIVED

PMID: 35608264 (View on PubMed)

Other Identifiers

Transregio79B8

Identifier Type: -

Identifier Source: org_study_id