Bone MarrowPERFOSNCT02371824
Study of Normal Hip and Lumbar Bone Marrow With Dynamic Contrast Enhancement Magnetic Resonance Imaging
An observational study of Bone Marrow, run by University Hospital, Lille at 1 site in France.
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)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bone Marrow
- What is being tested?
- MRI sequence
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- MRI sequence
- Keywords
- Magnetic Resonance Imaging, Bone Marrow, Hip, Lumbar Vertebrae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI sequenceOther
Also called Supplementary MRI sequence
One supplementary MRI sequence Dynamic Contrast Enhancement (DCE) was added to the clinical protocol.
| Study group | Role | What they receive |
|---|---|---|
| MRI Sequence | Not described Receives: Other: MRI sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of transfer constant (Ktrans)
This measure reflecting tissular perfusion is made in all the regions of interest.
Measured: On the day of the visit
Measure of rate constant (Kep)
This measure reflecting tissular perfusion is made in all the regions of interest.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On the day of the visit
Secondary outcomes (8)
Gender ratio
In all the regions of interest, we sought for statistical correlation with the perfusion parameters listed as primary outcome measurements.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: On the day of the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MarrowStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne COTTEN, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371824
- Sponsor's protocol ID
- 2013_47
- Other IDs
- 2013-A01708-37
- Acronym
- PERFOS
- Status last verified
- Feb 2015
- First submitted
- 5 Jan 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Normal Hip and Lumbar Bone Marrow With Dynamic Contrast Enhancement Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02371824
- Acronym / sponsor ID
- PERFOS / 2013_47
- Conditions
- Bone Marrow
- Keywords
- Magnetic Resonance Imaging, Bone Marrow, Hip, Lumbar Vertebrae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Sequence | – | Other: MRI sequence |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI sequenceAlso: Supplementary MRI sequenceOne supplementary MRI sequence Dynamic Contrast Enhancement (DCE) was added to the clinical protocol. | Other | MRI Sequence |
Primary outcome
Measure of transfer constant (Ktrans)
Time frame: On the day of the visit
This measure reflecting tissular perfusion is made in all the regions of interest.
Measure of rate constant (Kep)
Time frame: On the day of the visit
This measure reflecting tissular perfusion is made in all the regions of interest.
Measure of extra-vascular extra-cellular space (Ve)
Time frame: On the day of the visit
This measure reflecting tissular perfusion is made in all the regions of interest.
Measure of the initial slope (IS) of the Time-Concentration Curves
Time frame: On the day of the visit
This measure reflecting tissular perfusion is made in all the regions of interest.
Measure of the area under the curve (AUC) on the Time-Concentration Curves
Time frame: On the day of the visit
This measure reflecting tissular perfusion is made in all the regions of interest.
Measure of the time to peak (TTP) on the Time-Concentration Curves
Time frame: On the day of the visit
This measure reflecting tissular perfusion is made in all the regions of interest.
8 secondary outcomes
Gender ratio
Time frame: On the day of the visit
Age ratio
Time frame: On the day of the visit
body mass index
Time frame: On the day of the visit
number of smokers
Time frame: On the day of the visit
number of alcohol consumers
Time frame: On the day of the visit
number of participants with diabetes
Time frame: On the day of the visit
number of participants with hypertension
Time frame: On the day of the visit
number of participants with hypercholesterolemia
Time frame: On the day of the visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne COTTEN, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of transfer constant (Ktrans) (time frame: On the day of the visit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.