OsteoporosisNCT01374412
Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging
An observational study of Osteoporosis and Multiple Myeloma, run by German Cancer Research Center at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Multiple Myeloma, Vertebral Fracture
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with benign osteoporosis
Who may be able to join
- benign osteoporosis
Who cannot join
- contra-indications for MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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:
- Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI
- Functional MRI has prognostic value regarding occurrence of osteolysis and progression to MM regarding SLIM-CRAB-Criteria
Read the 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
- Medical subject headings
- Osteoporosis, Multiple Myeloma, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| osteoporosis | patients with benign osteoporosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of microcirculation at the interface between bone and implanted xenomaterial in animal models.
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.
Measured: VCT and MRI 2-6 weeks after xenomaterial implantation
Progression to multiple myeloma defined by SLIM-CRAB-Criteria (Rajkumar, Lancet Oncology, 2014)
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
Measured: 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 outcomes (1)
Occurrence of osteolysis
In the study part applying functional imaging in asymptomatic myeloma patients, occurrence of osteolysis in x-ray / CT imaging is the secondary outcome measure.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startJul 2010
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Reinhard Schnettler, MD, Study chair, Gießen University, Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374412
- Sponsor's protocol ID
- Transregio79B8
- Status last verified
- Aug 2022
- First submitted
- 14 Apr 2010
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25439696Wennmann 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.
PubMed 35640004Wennmann 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.
PubMed 35608264
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Bone Defects and Microcirculation Using Volume Computed Tomography and Dynamic Contrast-enhanced Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01374412
- Acronym / sponsor ID
- Transregio79B8
- Conditions
- Osteoporosis, Multiple Myeloma, Vertebral Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Jul 2010
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| osteoporosis | – | –patients with benign osteoporosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with benign osteoporosis
Key inclusion criteria (1 listed)
- benign osteoporosis
Key exclusion criteria (1 listed)
- contra-indications for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 25439696Rajkumar 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.
- Derived from this study: PubMed 35640004Wennmann 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.
- Derived from this study: PubMed 35608264Wennmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reinhard Schnettler, MD study chair
Gießen University, Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Multiple Myeloma, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01374412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.