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

Bone Marrow Clinical Trial

— PERFOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371824
• Other study ID #: 2013_47
• Secondary ID: 2013-A01708-37
• Status: Completed
• Phase: N/A
• First received: January 5, 2015
• Last updated: February 19, 2015
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: February 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bone Marrow

Intervention

Other:
• MRI sequence
One supplementary MRI sequence Dynamic Contrast Enhancement (DCE) was added to the clinical protocol.

Locations

Country	Name	City	State
France	Hospital Center Roger Salengro	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of transfer constant (Ktrans)	This measure reflecting tissular perfusion is made in all the regions of interest.	On the day of the visit	No
Primary	Measure of rate constant (Kep)	This measure reflecting tissular perfusion is made in all the regions of interest.	On the day of the visit	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No