An interventional study of T1 mapping and MR perfusion acquisition in Osteonecrosis, Pseudarthrosis and Compartment Syndrome, sponsored by Central Hospital, Nancy, France. Status unknown at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-23.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic
Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system.
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.
286 studies on the registry are indexed under Osteonecrosis; 45 are open to participants now.
This study's planned enrollment of 400 is above the median of 68 across 151 interventional studies indexed under Osteonecrosis.
Browse Osteonecrosis studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with normal bone appearance on conventional MR images
Other: T1 mapping and MR perfusion acquisition
Patients presenting signal anomalies compatible with osteonecrosis of the carpal bones on conventional MR images (hypointensity on T1 weighted sequences, no contrast enhancement).
Other: T1 mapping and MR perfusion acquisition
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).
Other: T1 mapping and MR perfusion acquisition
Patients presenting a non consolidated macroscopic bone fracture for over 6 months (clinical history and imaging findings).
Other: T1 mapping and MR perfusion acquisition
Patients with a confirmed compartment syndrome on intra-compartment pressure assessement
Other: T1 mapping and MR perfusion acquisition
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
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
Time frame: 3 years
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.
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.
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.
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.
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.
Time frame: First 6 months of inclusion
Started Feb 2016 (actual). Primary completion is estimated for Feb 2019, 36 months after the start.
Of 45 interventional studies with no phase under Osteonecrosis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 91. This study's planned 36 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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