NCT02371824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

January 5, 2015

Last Update Submit

February 19, 2015

Conditions

Bone Marrow

Keywords

Magnetic Resonance ImagingBone MarrowHipLumbar Vertebrae

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (8)

  • Gender ratio

    On the day of the visit

  • Age ratio

    On the day of the visit

  • body mass index

    On the day of the visit

  • number of smokers

    On the day of the visit

  • number of alcohol consumers

    On the day of the visit

  • +3 more secondary outcomes

Study Arms (1)

MRI Sequence

Other: MRI sequence

Interventions

MRI sequenceOTHER

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

Also known as: Supplementary MRI sequence
MRI Sequence

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Center Roger Salengro

Lille, 59037, France

Location

Study Officials

  • Anne COTTEN, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2015

First Posted

February 26, 2015

Study Start

April 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 26, 2015

Record last verified: 2015-02

Locations

FR(1)