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

NCT ID: NCT02371824

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-10-31

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.

Conditions

Bone Marrow

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

MRI Sequence

MRI sequence

Intervention Type: OTHER

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

Interventions

MRI sequence

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

Intervention Type: OTHER

Other Intervention Names

Supplementary MRI sequence

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne COTTEN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hospital Center Roger Salengro

Lille, , France

Countries

France

Other Identifiers

2013-A01708-37

Identifier Type: OTHER

Identifier Source: secondary_id

2013_47

Identifier Type: -

Identifier Source: org_study_id