Low Back PainADCNCT02738424
Reproductibility of Lumbar Spine ADC Based on Different Post-processing Softwares
An observational study of Low Back Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Lumbar spine bone marrow is well explored in Magnetic Resonance Imaging (MRI) but some bone marrow diseases are hard to analyze with this method. Furthermore, there is heterogeneity in normal bone marrow, called apparent diffusion coefficient (ADC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Calculate the ADC scores
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2015to 16 Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population studied is composed of 100 patients that will performed an MRI in the CHU de Saint-Etienne. They have lumbar pain, and the MRI is indicated off-study.
Who may be able to join
- Consecutive patients undergoing lumbar spine MRI at University Hospital of Saint-Etienne
Who cannot join
- <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Lumbar spine bone marrow is well explored in Magnetic Resonance Imaging (MRI) but some bone marrow diseases are hard to analyze with this method. Furthermore, there is heterogeneity in normal bone marrow, called apparent diffusion coefficient (ADC). Histological and technical factors appear to be the cause, but the possible influence of the employed post-processing software has never yet been evaluated. The purpose of this study is to determine if there is variability in lumbar bone ADC related to the post-processing software.
Read the detailed description
Lumbar spine bone marrow is well explored in MRI. Some bone marrow diseases are hard to analyze in conventional MRI, and diffusion-weighted imaging (DWI) could be an additional diagnostic feature. However, according to the literature, there is heterogeneity in normal bone marrow of the quantitative parameter that it provides, called apparent diffusion coefficient (ADC). Histological and technical factors appear to be the cause, but the possible influence of the employed post-processing software has never yet been evaluated. The purpose of this study is to determine if there is variability in lumbar bone ADC related to the post-processing software.
- Conditions
- Low Back Pain
- Being tested
- Calculate the ADC scores
- Keywords
- Low Back Pain, MRI
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculate the ADC scoresOther
The MRI will be performed on the two groups of patients in the usual care. The intervention will be based on the ADC scores calculation. The scores will be obtained with three types of post-processing softwares : Siemens, PACS Carestream, Osirix.
| Study group | Role | What they receive |
|---|---|---|
| 3T patients : Calculate the ADC scores | In this group all the patients perform a 3 Tesla RMI. With these data, three methods will be used to calculate the ADC score : Siemens, PACS (picture archiving and communication system) Carestream, Osirix. The ADC scores obtained with these three post-processing softwares will be compared. Receives: Other: Calculate the ADC scores | |
| 1.5T patients : Calculate the ADC scores | In this group all the patients perform a 1,5 Tesla RMI. With these data, three methods will be used to calculate the ADC score : Siemens, PACS Carestream, Osirix. The ADC scores obtained with these three post-processing softwares will be compared. Receives: Other: Calculate the ADC scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADC Score according to the post-processing software used
The ADC Score will be calculated for each patient, with three different post-processing softwares : Siemens, PACS (picture archiving and communication system) Carestream, Osirix. The scores will be compared, because the aim of this study is to demonstrate the variability of this score, according to the post-processing software used.
Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue, and is commonly clinically calculated using Magnetic resonance imaging (MRI) with diffusion weighted imaging (DWI). An ADC of a tissue is expressed in units of mm2/s. There is no unanimity regarding the boundaries of the range of normal diffusion, but ADC values less than 1.0 to 1.1 x 10-3 mm2/s (or 1000-1100 x 10-6 mm2/s) are generally acknowledged in adults as indicating restriction.
Measured: 1 day
Secondary outcomes (1)
ADC Score according to the intensity of MRI
The ADC Score will also be compared to the intensity of the Magnetic resonance imaging (MRI) performed for each patient. Half have received a MRI of 1,5 Tesla and the other hand a 3 Tesla MRI. The variability between these two groups will be compared in the secondary outcome.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start1 Apr 2015
- Primary completion16 Nov 2015
- Study completion16 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire BOUTET, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738424
- Sponsor's protocol ID
- IRBN642015/CHUSTE
- Acronym
- ADC
- Status last verified
- Jul 2023
- First submitted
- 11 Apr 2016
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductibility of Lumbar Spine ADC Based on Different Post-processing Softwares
- ClinicalTrials.gov ID
- NCT02738424
- Acronym / sponsor ID
- ADC / IRBN642015/CHUSTE
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 16 Nov 2015 (actual)
- Study completion
- 16 Nov 2015 (actual)
- First posted
- 14 Apr 2016 (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.
Lumbar spine bone marrow is well explored in Magnetic Resonance Imaging (MRI) but some bone marrow diseases are hard to analyze with this method. Furthermore, there is heterogeneity in normal bone marrow, called apparent diffusion coefficient (ADC). Histological and technical factors appear to be the cause, but the possible influence of the employed post-processing software has never yet been evaluated. The purpose of this study is to determine if there is variability in lumbar bone ADC related to the post-processing software.
Detailed description
Lumbar spine bone marrow is well explored in MRI. Some bone marrow diseases are hard to analyze in conventional MRI, and diffusion-weighted imaging (DWI) could be an additional diagnostic feature. However, according to the literature, there is heterogeneity in normal bone marrow of the quantitative parameter that it provides, called apparent diffusion coefficient (ADC). Histological and technical factors appear to be the cause, but the possible influence of the employed post-processing software has never yet been evaluated. The purpose of this study is to determine if there is variability in lumbar bone ADC related to the post-processing software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3T patients : Calculate the ADC scores | – | Other: Calculate the ADC scoresIn this group all the patients perform a 3 Tesla RMI. With these data, three methods will be used to calculate the ADC score : Siemens, PACS (picture archiving and communication system) Carestream, Osirix. The ADC scores obtained with these three post-processing softwares will be compared. |
| 1.5T patients : Calculate the ADC scores | – | Other: Calculate the ADC scoresIn this group all the patients perform a 1,5 Tesla RMI. With these data, three methods will be used to calculate the ADC score : Siemens, PACS Carestream, Osirix. The ADC scores obtained with these three post-processing softwares will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied is composed of 100 patients that will performed an MRI in the CHU de Saint-Etienne. They have lumbar pain, and the MRI is indicated off-study.
Key inclusion criteria (1 listed)
- Consecutive patients undergoing lumbar spine MRI at University Hospital of Saint-Etienne
Key exclusion criteria (1 listed)
- <18 years old
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 |
|---|---|---|
| Calculate the ADC scoresThe MRI will be performed on the two groups of patients in the usual care. The intervention will be based on the ADC scores calculation. The scores will be obtained with three types of post-processing softwares : Siemens, PACS Carestream, Osirix. | Other | 1.5T patients : Calculate the ADC scores, 3T patients : Calculate the ADC scores |
Primary outcome
ADC Score according to the post-processing software used
Time frame: 1 day
The ADC Score will be calculated for each patient, with three different post-processing softwares : Siemens, PACS (picture archiving and communication system) Carestream, Osirix. The scores will be compared, because the aim of this study is to demonstrate the variability of this score, according to the post-processing software used. Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue, and is commonly clinically calculated using Magnetic resonance imaging (MRI) with diffusion weighted imaging (DWI). An ADC of a tissue is expressed in units of mm2/s. There is no unanimity regarding the boundaries of the range of normal diffusion, but ADC values less than 1.0 to 1.1 x 10-3 mm2/s (or 1000-1100 x 10-6 mm2/s) are generally acknowledged in adults as indicating restriction.
1 secondary outcome
ADC Score according to the intensity of MRI
Time frame: 1 day
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 20 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Claire BOUTET, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Low Back Pain, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 1 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 20 Jul 2023. 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?
ADC Score according to the post-processing software used (time frame: 1 day). 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 20 Jul 2023.