OsteonecrosisAFRONTNCT02683252
Musculoskeletal Non-tumoral Pathology Quantitative Perfusion
A study testing T1 mapping and MR perfusion acquisition in people with Osteonecrosis and Pseudarthrosis, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis, Pseudarthrosis, Compartment Syndrome
- What is being tested?
- T1 mapping and MR perfusion acquisition
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Feb 2016to 12 Feb 2020
- Phase
- Interventional
- 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
Who may be able to join
- affiliation to a social security regimen
- Signature of an informed consent
- Clinical suspicion of one of the studied conditions (osteonecrosis of the wrist, osteonecrosis of the femoral head, pseudarthrosis and compartment syndrome)
Who cannot join
- MR contraindications
- Contraindications to contrast injection
- Previous history of allergy to gadolinium containing contrast medium
- Presence of metallic hardware in the study zone
- Pregnancy
- Patients under tutelage
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CCIAL, CHRU-Lille
Lille, Hauts-de-France, 59036
Anne Cotten, MD, PhD, 0033 3 20 44 59 62, Vanessa.vandendooren@CHRU-LILLE.FR
Guillaume Lefebvre, MD, 0033 3 20 44 59 62, guillaume.lefebvre59@gmail.com
- Recruiting
Service d'Imagerie Guilloz, CHRU-Nancy
Nancy, Lorraine, 54000
Alain Blum, MD, PhD, 0033 3 83 85 21 61, alain.blum@gmail.com
Pedro Teixeira, MD, PhD, 0033 3 83 85 21 61, ped_gt@hotmail.com
About this study
Official title: Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system.
Read the detailed description
Patients referred for the MR imaging evaluation of non-tumoral musculoskeletal pathology (osteonecrosis, pseudarthrosis and compartment syndrome) will have their MR protocols complemented by a contrast enhanced perfusion study. In this patients standard clinical evaluation is already performed with contrast medium injection (Gadolinium) and no additional injection is required.
After post processing multiple quantitative perfusions parameters will be extracted (e.g. plasmatic volume, transfer constant, backflow constant, extra-cellular extra vascular space volume). The variation of these parameters in patients with and without the previously described conditions will be compared.
- Conditions
- Osteonecrosis, Pseudarthrosis, Compartment Syndrome
- Being tested
- T1 mapping and MR perfusion acquisition
- Keywords
- Magnetic resonance imaging, perfusion, quantitative
- Medical subject headings
- Osteonecrosis, Pseudarthrosis, Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1 mapping and MR perfusion acquisitionOther
One T1 mapping acquisition with variable flip angles will be performed before contrast injection. One perfusion 3D FSPGR sequence will be acquired after contrast injection
| Study group | Role | What they receive |
|---|---|---|
| Normal patients | Experimental | Patients with normal bone appearance on conventional MR images Receives: Other: T1 mapping and MR perfusion acquisition |
| Carpal osteonecrosis | Experimental | Patients presenting signal anomalies compatible with osteonecrosis of the carpal bones on conventional MR images (hypointensity on T1 weighted sequences, no contrast enhancement). Receives: Other: T1 mapping and MR perfusion acquisition |
| Femoral head osteonecrosis | Experimental | Patients presenting signal anomalies compatible with osteonecrosis of the femoral head on conventional MR images (fat containing signal anomalies with geographic contours in the femoral epiphysis). Receives: Other: T1 mapping and MR perfusion acquisition |
| Pseudarthrosis | Experimental | Patients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings). Receives: Other: T1 mapping and MR perfusion acquisition |
| Compartment syndrome | Experimental | Patients with a confirmed compartment syndrome on intra-compartment pressure assessement Receives: Other: T1 mapping and MR perfusion acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
The plasmatic volume (Vp%) in ml is a quantitative perfusion parameter that describes the capillar density of the tissues evaluated and can be useful in tissue characterization
Measured: 3 years
Secondary outcomes (3)
Variation of the plasma-extra-cellular space transfer constant in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
The plasma-extracellular space transfer constant (Ktrans) in min -1 is a quantitative perfusion parameter that is related to the capillar permeability and blood flow. This parameter can be useful for tissue characterization.
Measured: 3 years
Variation of the extra-cellular space-plasma transfer constant (backflow constant) in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
The extracellular-space-plasma transfer constant or backflow constant (Kep) in min -1 is a quantitative perfusion parameter that is related to the capillar permeability. This parameter can be useful for tissue characterization.
Measured: 3 years
Variation of the extra-cellular extra-vascular space volume in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
The extracellular-space extra-vascular space volume (Ve%) in ml is a quantitative perfusion parameter that is related to the tissue cellularity. This parameter can be useful for tissue characterization.
Measured: First 6 months of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study start12 Feb 2016
- Primary completion12 Feb 2019 (estimated)
- Study completion12 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683252
- Sponsor's protocol ID
- RCB: 2015-A01604-45
- Acronym
- AFRONT
- Status last verified
- Jul 2018
- First submitted
- 28 Jan 2016
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mueller D, Schaeffeler C, Baum T, Walter F, Rechl H, Rummeny EJ, Woertler K. Magnetic resonance perfusion and diffusion imaging characteristics of transient bone marrow edema, avascular necrosis and subchondral insufficiency fractures of the proximal femur. Eur J Radiol. 2014 Oct;83(10):1862-9. doi: 10.1016/j.ejrad.2014.07.017. Epub 2014 Jul 30.
PubMed 25129825Muller GM, Mansson S, Muller MF, Ekberg O, Bjorkman A. Assessment of perfusion in normal carpal bones with dynamic gadolinium-enhanced MRI at 3 Tesla. J Magn Reson Imaging. 2013 Jul;38(1):168-72. doi: 10.1002/jmri.23951. Epub 2012 Nov 27.
PubMed 23188589Bervian MR, Ribak S, Livani B. Scaphoid fracture nonunion: correlation of radiographic imaging, proximal fragment histologic viability evaluation, and estimation of viability at surgery: diagnosis of scaphoid pseudarthrosis. Int Orthop. 2015 Jan;39(1):67-72. doi: 10.1007/s00264-014-2579-4. Epub 2014 Nov 16.
PubMed 25398469Rominger MB, Lukosch CJ, Bachmann GF. MR imaging of compartment syndrome of the lower leg: a case control study. Eur Radiol. 2004 Aug;14(8):1432-9. doi: 10.1007/s00330-004-2305-5. Epub 2004 Apr 6.
PubMed 15067424Teixeira PA, Chanson A, Beaumont M, Lecocq S, Louis M, Marie B, Sirveaux F, Blum A. Dynamic MR imaging of osteoid osteomas: correlation of semiquantitative and quantitative perfusion parameters with patient symptoms and treatment outcome. Eur Radiol. 2013 Sep;23(9):2602-11. doi: 10.1007/s00330-013-2867-1. Epub 2013 May 22.
PubMed 23695220
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology
- ClinicalTrials.gov ID
- NCT02683252
- Acronym / sponsor ID
- AFRONT / RCB: 2015-A01604-45
- Conditions
- Osteonecrosis, Pseudarthrosis, Compartment Syndrome
- Keywords
- Magnetic resonance imaging, perfusion, quantitative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 12 Feb 2019 (estimated)
- Study completion
- 12 Feb 2020 (estimated)
- First posted
- 17 Feb 2016 (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.
Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system.
Detailed description
Patients referred for the MR imaging evaluation of non-tumoral musculoskeletal pathology (osteonecrosis, pseudarthrosis and compartment syndrome) will have their MR protocols complemented by a contrast enhanced perfusion study. In this patients standard clinical evaluation is already performed with contrast medium injection (Gadolinium) and no additional injection is required.
After post processing multiple quantitative perfusions parameters will be extracted (e.g. plasmatic volume, transfer constant, backflow constant, extra-cellular extra vascular space volume). The variation of these parameters in patients with and without the previously described conditions will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal patients | Experimental | Other: T1 mapping and MR perfusion acquisitionPatients with normal bone appearance on conventional MR images |
| Carpal osteonecrosis | Experimental | Other: T1 mapping and MR perfusion acquisitionPatients presenting signal anomalies compatible with osteonecrosis of the carpal bones on conventional MR images (hypointensity on T1 weighted sequences, no contrast enhancement). |
| Femoral head osteonecrosis | Experimental | Other: T1 mapping and MR perfusion acquisitionPatients presenting signal anomalies compatible with osteonecrosis of the femoral head on conventional MR images (fat containing signal anomalies with geographic contours in the femoral epiphysis). |
| Pseudarthrosis | Experimental | Other: T1 mapping and MR perfusion acquisitionPatients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings). |
| Compartment syndrome | Experimental | Other: T1 mapping and MR perfusion acquisitionPatients with a confirmed compartment syndrome on intra-compartment pressure assessement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- affiliation to a social security regimen
- Signature of an informed consent
- Clinical suspicion of one of the studied conditions (osteonecrosis of the wrist, osteonecrosis of the femoral head, pseudarthrosis and compartment syndrome)
Key exclusion criteria (6 listed)
- MR contraindications
- Contraindications to contrast injection
- Previous history of allergy to gadolinium containing contrast medium
- Presence of metallic hardware in the study zone
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T1 mapping and MR perfusion acquisitionOne T1 mapping acquisition with variable flip angles will be performed before contrast injection. One perfusion 3D FSPGR sequence will be acquired after contrast injection | Other | Carpal osteonecrosis, Compartment syndrome, Femoral head osteonecrosis, Normal patients, Pseudarthrosis |
Primary outcome
Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
Time frame: 3 years
The plasmatic volume (Vp%) in ml is a quantitative perfusion parameter that describes the capillar density of the tissues evaluated and can be useful in tissue characterization
3 secondary outcomes
Variation of the plasma-extra-cellular space transfer constant in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
Time frame: 3 years
Variation of the extra-cellular space-plasma transfer constant (backflow constant) in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
Time frame: 3 years
Variation of the extra-cellular extra-vascular space volume in the 5 study groups (arms) and between the images acquired in the two inclusion sites.
Time frame: First 6 months of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Background: PubMed 25129825Mueller D, Schaeffeler C, Baum T, Walter F, Rechl H, Rummeny EJ, Woertler K. Magnetic resonance perfusion and diffusion imaging characteristics of transient bone marrow edema, avascular necrosis and subchondral insufficiency fractures of the proximal femur. Eur J Radiol. 2014 Oct;83(10):1862-9. doi: 10.1016/j.ejrad.2014.07.017. Epub 2014 Jul 30.
- Background: PubMed 23188589Muller GM, Mansson S, Muller MF, Ekberg O, Bjorkman A. Assessment of perfusion in normal carpal bones with dynamic gadolinium-enhanced MRI at 3 Tesla. J Magn Reson Imaging. 2013 Jul;38(1):168-72. doi: 10.1002/jmri.23951. Epub 2012 Nov 27.
- Background: PubMed 25398469Bervian MR, Ribak S, Livani B. Scaphoid fracture nonunion: correlation of radiographic imaging, proximal fragment histologic viability evaluation, and estimation of viability at surgery: diagnosis of scaphoid pseudarthrosis. Int Orthop. 2015 Jan;39(1):67-72. doi: 10.1007/s00264-014-2579-4. Epub 2014 Nov 16.
- Background: PubMed 15067424Rominger MB, Lukosch CJ, Bachmann GF. MR imaging of compartment syndrome of the lower leg: a case control study. Eur Radiol. 2004 Aug;14(8):1432-9. doi: 10.1007/s00330-004-2305-5. Epub 2004 Apr 6.
- Results publication: PubMed 23695220Teixeira PA, Chanson A, Beaumont M, Lecocq S, Louis M, Marie B, Sirveaux F, Blum A. Dynamic MR imaging of osteoid osteomas: correlation of semiquantitative and quantitative perfusion parameters with patient symptoms and treatment outcome. Eur Radiol. 2013 Sep;23(9):2602-11. doi: 10.1007/s00330-013-2867-1. Epub 2013 May 22.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T1 mapping and MR perfusion acquisition in people with Osteonecrosis and Pseudarthrosis, run by Central Hospital, Nancy, France at 2 sites in France.
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 3 inclusion and 6 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Contact Pedro TEIXEIRA, MD, PhD (33 (3) 83 85 21 61, ped_gt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the plasmatic volume estimation in the 5 study groups (arms) and between the images acquired in the two inclusion sites. (time frame: 3 years). 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 NCT02683252, which also lists 5 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 23 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.