An observational study in Bone Marrow, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by University Hospital, Lille · Observational
DCE-MRI were performed in sixty adults (hips and lumbar spine). For each region of interest studied, the investigators determined the morphology of each time-concentration curve (TCC) and calculated semi-quantitative and pharmacokinetic parameters: initial slope (IS), area under the curve (AUC), time to peak (TTP), Ktrans, Kep and Ve. Clinical data were collected anamnestically.
MRI protocol Patients were examined on a 3T MR scan (Ingenia, Philips Healthcare, The Netherlands). Conventional sequences were acquired depending on the clinical problem. A T1 spin echo sequence imaged the right hip in the coronal plane. A previously described Dynamic 3D T1 Spoiled Gradient Echo covered the right hip (8). Its main features were as follows. 94 axial slices covered a Field of View (FOV) of 228 x 130 x 169 mm. TR, TE, flip angle and bandwidth per pixel were respectively 4.5 and 2.1 ms, 10°, 389 Hz. Acquisition and reconstruction matrix were 64 x 66 and 128 x 128 respectively. Temporal resolution was 13.5 seconds.
Three variable flip angles (VFA) sequences (3°, 10° and 17°) were acquired before injection. Each acquisition lasted 55 seconds. Five baseline scans were acquired. 0.1 mmol/kg of gadoteric acid (DOTAREM, Guerbet, France) were injected at the beginning of the sixth scan at a rate of 2.5ml/sec followed by 20cc of saline flush. Twenty dynamic scans were collected. Total examination time was 9 minutes.
Post-processing The investigators analyzed DCE images with the open-source software Osirix and DCE tool software (http://kyungs.bol.ucla.edu/software/DCE_tool/DCE_tool.html). A ROI was deposed in the common femoral artery to determine Arterial Input Function. T1 map was calculated from VFA acquisitions. The precise r1 relaxivity (3.4) of the contrast agent was introduced. These elements were used to calculate the time / gadolinium concentration curve. Tofts model was used.
The morphology of the curve was assessed visually according to the description made by van Rijswik (10). For each ROI, semi-quantitative and pharmacokinetic parameters were calculated: initial slope (IS), area under the curve (AUC), time to peak (TTP), transfer constant (Ktrans), rate constant (Kep) and extravascular-extracellular space volume (Ve). IS calculation included points 5 to 15. AUC and TTP were calculated from points 5 to 25. Parametric maps were obtained for the illustration of this work, but were not used for the analysis itself in order to avoid bias in the deposition of ROIs.
University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients referred to the musculoskeletal imaging department for a MRI examination of the hip or sacro-iliac joints with normal appearing bones on MR images.
Exclusion Criteria:
Other: MRI sequence
One supplementary MRI sequence Dynamic Contrast Enhancement (DCE) was added to the clinical protocol.
Also known as: Supplementary MRI sequence
Measure of transfer constant (Ktrans)
This measure reflecting tissular perfusion is made in all the regions of interest.
Time frame: On the day of the visit
Measure of rate constant (Kep)
This measure reflecting tissular perfusion is made in all the regions of interest.
Time frame: On the day of the visit
Measure of extra-vascular extra-cellular space (Ve)
This measure reflecting tissular perfusion is made in all the regions of interest.
Time frame: On the day of the visit
Measure of the initial slope (IS) of the Time-Concentration Curves
This measure reflecting tissular perfusion is made in all the regions of interest.
Time frame: On the day of the visit
Measure of the area under the curve (AUC) on the Time-Concentration Curves
This measure reflecting tissular perfusion is made in all the regions of interest.
Time frame: On the day of the visit
Measure of the time to peak (TTP) on the Time-Concentration Curves
This measure reflecting tissular perfusion is made in all the regions of interest.
Time frame: On the day of the visit
Gender ratio
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Time frame: On the day of the visit
Age ratio
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Time frame: On the day of the visit
body mass index
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Time frame: On the day of the visit
number of smokers
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Time frame: On the day of the visit
number of alcohol consumers
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Time frame: On the day of the visit
number of participants with diabetes
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Time frame: On the day of the visit
number of participants with hypertension
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Time frame: On the day of the visit
number of participants with hypercholesterolemia
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Time frame: On the day of the visit
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Lille