Iron Hepatic OverloadHEMOCOMPARENCT03200457
Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla
A study testing 1,5 Tesla abdominal MRI and 3 Tesla abdominal MRI in people with Iron Hepatic Overload and Fat Hepatic Overload, run by Rennes University Hospital at 2 sites in France.
Trial summary
The study proposes to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Hepatic Overload, Fat Hepatic Overload
- What is being tested?
- 1,5 Tesla abdominal MRI and 3 Tesla abdominal MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Jul 2018to 28 Aug 2020
- Phase
- Interventional
- 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
Who may be able to join
- Adult 18 years of age or older;
- Having an MRI indication of iron and fat quantification;
- Benefiting from social security;
- Having given a free, informed and written consent.
Who cannot join
- Related to MRI
- Implantable cardiac pacemaker or defibrillator;
- Non-MRI cardiac valve compatible;
- Clips, stents, coils, etc ... no MRI compatible;
- Cochlear implants;
- Neuronal or peripheral stimulator;
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- Foreign bodies metallic intra orbital or encephalic, foreign body close to the eyes, wound by metallic lash (war, ball);
- Endoprostheses placed for less than 4 weeks and osteosynthesis materials placed less than 6 weeks old;
- Claustrophobia;
- Pumps, tattoos, permanent make-up, intrauterine device, patches;
- Metallic, magnetic, non-removable material and close to the analysis field.
- Other criteria
- unstable hemodynamic status, acute respiratory failure, general precarious condition or a need for continuous monitoring incompatible with MRI constraints;
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
- Known pregnancy, breastfeeding.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital St Vincent du Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille
CHU de Rennes
Rennes, 35033
About this study
The study proposes to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients.
Read the detailed description
Quantification of hepatic iron by MRI is validated at 1.5 Tesla on a small number of subjects with some discrepancies between the two most used techniques (liver to muscle ratio or calculation of the decay rate of the T2 * signal). Since the initial publications at 1.5 Tesla, new technical innovations have emerged which can allow better quantification. Recently, the investigators have applied these innovations to Rennes and have validated (SURFER study) the possibility of making a quantification of iron and fat on two 3 Tesla devices with good results in a single apnea acquisition. But it is not uncommon to have, in a structure, different magnetic field devices, and it is important to ensure that the results are transposable. It is also crucial for multicentre or cohort studies to ensure consistency. It is therefore proposed to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients.
- Conditions
- Iron Hepatic Overload, Fat Hepatic Overload
- Being tested
- 1,5 Tesla abdominal MRI, 3 Tesla abdominal MRI
- Keywords
- Liver iron, Liver steatosis, MRI
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,5 Tesla abdominal MRIDevice
Measurement of the fat and iron
3 Tesla abdominal MRIDevice
Measurement of the fat and iron
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatic iron overload or steatosis | Experimental | Each patient (80) will have two MRI exams on the same day: one performed in common practice on a 1.5 Tesla device and the other on a 3 Tesla device. Receives: Device: 1,5 Tesla abdominal MRI; Device: 3 Tesla abdominal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the agreement of the measurement of the fat and iron obtained by MRI, based on our previous calibrations (MRQuantif software), on two MRI devices.
Bland and Altman method comparing the quantification of iron and liver fat provided by the two MRI devices in the same patient using the MRQuantif software developed by the imaging department of the University Hospital of Rennes :
- a 1.5 Tesla device
- a 3 Tesla device
Measured: Day 1
Secondary outcomes (3)
Study of the concordance of the estimation of the quantification of the iron and the hepatic fat provided by our method and those of the constructors
Concordance of the estimation of the quantification of the iron and the hepatic fat provided by our method and those of the constructors
Measured: Day 1
Analysis of the repeatability of the measurement (two acquisitions for each study).
Intraclass correlation coefficients (ICCs) and Bland \& Altmann between two acquisitions
Measured: Day 1
Analysis of the intra or interobserver reproducibility (several analysis for a single acquisition).
Intraclass correlation coefficients (ICCs) and Bland \& Altmann between two readers/readings
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start20 Jul 2018
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Hepatic OverloadStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Gandon, MD, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200457
- Sponsor's protocol ID
- 2017-A01291-52
- Acronym
- HEMOCOMPARE
- Status last verified
- Feb 2022
- First submitted
- 22 Jun 2017
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Variability of Hepatic Load Quantification in Iron and Fat Estimated by MRI at 1.5 and 3 Tesla
- ClinicalTrials.gov ID
- NCT03200457
- Acronym / sponsor ID
- HEMOCOMPARE / 2017-A01291-52
- Conditions
- Iron Hepatic Overload, Fat Hepatic Overload
- Keywords
- Liver iron, Liver steatosis, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 27 Jun 2017 (actual)
- 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.
The study proposes to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients.
Detailed description
Quantification of hepatic iron by MRI is validated at 1.5 Tesla on a small number of subjects with some discrepancies between the two most used techniques (liver to muscle ratio or calculation of the decay rate of the T2 * signal). Since the initial publications at 1.5 Tesla, new technical innovations have emerged which can allow better quantification. Recently, the investigators have applied these innovations to Rennes and have validated (SURFER study) the possibility of making a quantification of iron and fat on two 3 Tesla devices with good results in a single apnea acquisition. But it is not uncommon to have, in a structure, different magnetic field devices, and it is important to ensure that the results are transposable. It is also crucial for multicentre or cohort studies to ensure consistency. It is therefore proposed to compare the results of two examinations at 1.5 and 3 Tesla obtained on the same day on a series of 80 patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatic iron overload or steatosis | Experimental | Device: 1,5 Tesla abdominal MRI, Device: 3 Tesla abdominal MRIEach patient (80) will have two MRI exams on the same day: one performed in common practice on a 1.5 Tesla device and the other on a 3 Tesla device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult 18 years of age or older;
- Having an MRI indication of iron and fat quantification;
- Benefiting from social security;
- Having given a free, informed and written consent.
Key exclusion criteria (15 listed)
- Related to MRI
- Implantable cardiac pacemaker or defibrillator;
- Non-MRI cardiac valve compatible;
- Clips, stents, coils, etc ... no MRI compatible;
- Cochlear implants;
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 |
|---|---|---|
| 1,5 Tesla abdominal MRIMeasurement of the fat and iron | Device | Patients with hepatic iron overload or steatosis |
| 3 Tesla abdominal MRIMeasurement of the fat and iron | Device | Patients with hepatic iron overload or steatosis |
Primary outcome
Study of the agreement of the measurement of the fat and iron obtained by MRI, based on our previous calibrations (MRQuantif software), on two MRI devices.
Time frame: Day 1
Bland and Altman method comparing the quantification of iron and liver fat provided by the two MRI devices in the same patient using the MRQuantif software developed by the imaging department of the University Hospital of Rennes : * a 1.5 Tesla device * a 3 Tesla device
3 secondary outcomes
Study of the concordance of the estimation of the quantification of the iron and the hepatic fat provided by our method and those of the constructors
Time frame: Day 1
Analysis of the repeatability of the measurement (two acquisitions for each study).
Time frame: Day 1
Analysis of the intra or interobserver reproducibility (several analysis for a single acquisition).
Time frame: Day 1
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 15 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Iron Hepatic Overload
RecruitingObservational study
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Chronic Liver Disease
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.
Yves Gandon, MD, PhD principal investigator
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1,5 Tesla abdominal MRI and 3 Tesla abdominal MRI in people with Iron Hepatic Overload and Fat Hepatic Overload, run by Rennes University Hospital at 2 sites 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 15 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Study of the agreement of the measurement of the fat and iron obtained by MRI, based on our previous calibrations (MRQuantif software), on two MRI devices. (time frame: Day 1). 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 15 Feb 2022.