Clinical trial NCT02371824: Study of Normal Hip and Lumbar Bone Marrow With Dynamic Contrast Enhancement Magnetic Resonance Imaging
Official title: Study of Normal Hip and Lumbar Bone Marrow With Dynamic Contrast Enhancement Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow
Keywords: Magnetic Resonance Imaging
Bone Marrow
Hip
Lumbar Vertebrae
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Major patients
* patients who requires MRI examination of the hip or sacro-iliac joints
* patients who required a gadolinium injection for the clinical needs were included.
* normal appearing bones on MR images.

Exclusion Criteria:

* Patients under 18 years old,
* pregnant women, prisoners,
* patients unable to give informed consent,
* patients very painful and non-cooperative patients,
* Absolute contraindication to 3Tesla MRI (pacemaker, implantable pacemaker, metallic foreign body intraorbital)
* patients with previous or current history of hip, neoplastic, inflammatory or hematologic diseases, known osteoporosis or osteopenia, hip orthopedic hardware, chronic renal failure, known hyperparathyroidism, known acute or chronic inflammatory syndrome.
* abnormalities of the hip bones were seen on MR images, the patient was not included.

Primary outcomes:
measure: Measure of transfer constant (Ktrans)
timeFrame: On the day of the visit
measure: Measure of rate constant (Kep)
timeFrame: On the day of the visit
measure: Measure of extra-vascular extra-cellular space (Ve)
timeFrame: On the day of the visit
measure: Measure of the initial slope (IS) of the Time-Concentration Curves
timeFrame: On the day of the visit
measure: Measure of the area under the curve (AUC) on the Time-Concentration Curves
timeFrame: On the day of the visit
measure: Measure of the time to peak (TTP) on the Time-Concentration Curves
timeFrame: On the day of the visit
Secondary outcomes:
measure: Gender ratio
timeFrame: On the day of the visit
measure: Age ratio
timeFrame: On the day of the visit
measure: body mass index
timeFrame: On the day of the visit
measure: number of smokers
timeFrame: On the day of the visit
measure: number of alcohol consumers
timeFrame: On the day of the visit
measure: number of participants with diabetes
timeFrame: On the day of the visit
measure: number of participants with hypertension
timeFrame: On the day of the visit
measure: number of participants with hypercholesterolemia
timeFrame: On the day of the visit
Other outcomes:
Locations:
city: Lille
country: France
facility: Hospital Center Roger Salengro
Study officials:
affiliation: University Hospital, Lille
name: Anne COTTEN, MD
role: PRINCIPAL_INVESTIGATOR
References: