Study of Normal Hip and Lumbar Bone Marrow With Dynamic Contrast Enhancement Magnetic Resonance Imaging (PERFOS)

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.

Study Overview

• Status: Completed
• Conditions: Bone Marrow
• Intervention / Treatment: Other: MRI sequence

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hospital Center Roger Salengro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRI Sequence	Other: MRI sequence; One supplementary MRI sequence Dynamic Contrast Enhancement (DCE) was added to the clinical protocol.; Other Names: Supplementary MRI sequence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of transfer constant (Ktrans)	This measure reflecting tissular perfusion is made in all the regions of interest.	On the day of the visit
Measure of rate constant (Kep)	This measure reflecting tissular perfusion is made in all the regions of interest.	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.	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.	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.	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.	On the day of the visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender ratio	In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.	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.	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.	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.	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.	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.	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.	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.	On the day of the visit

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Anne COTTEN, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): February 26, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Hip; Bone Marrow; Lumbar Vertebrae
• Other Study ID Numbers: 2013_47; 2013-A01708-37 (Other Identifier: ID-RDB number, ANSM)