Pancreatic CancerPAIR-PANCREASNCT04007640
Early Screening of Pancreatic Lesions : Development of New Imaging Tools
A study testing MRI with additional sequences, MRI and Left pancreatectomy or pancreaticoduodenectomy in people with Pancreatic Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Obesity, diabetes and metabolic syndrome (MS) have all been associated with increase of pancreatic cancer (PK) risk. The precise role of obesity and diabetes and the pathways involved in the early oncogenic phases of PK associated with MS are not well known. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- MRI with additional sequences, MRI and Left pancreatectomy or pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2019to 31 May 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1st stage : Volunteers without history of known pancreatic disorders
- Adults
- 2nd stage : Obese Volunteers
- Adults with planned hepatic MRI
- Obese (BMI ≥30)
- 3rd stage : Patients
- Adults (aged 18-65 years) with a planned pancreatic surgery for benign pancreatic lesions (IPMN, cystic lesions or neuroendocrine tumors)
- Obese (BMI≥30), overweight (25≤BMI≤29.9) or non-obese patients (18.5<BMI<24.9)
Who cannot join
- For volunteers without history of known pancreatic disorders (1st stage):
- Symptoms or past medical history suggesting pancreatic disorders
- For all participants (1st, 2nd and 3rd stages) :
- Patients with contraindication to MRI (pacemaker, claustrophobia…)
- Inability to undergo MRI due to weight excess
- Pregnant or breastfeeding woman
Show all 9Show fewer
- Absence of free and informed consent
- Non affiliation to a social security regime or CMU
- Subject deprived of freedom, subject under a legal protective measure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Stages of Pancreatic Cancer Associated With Obesity and Metabolic Syndrome: Prevention and Screening Tools - Imaging of Fatty Pancreas in Humans: Correlation With Pathological Analysis
Obesity, diabetes and metabolic syndrome (MS) have all been associated with increase of pancreatic cancer (PK) risk. The precise role of obesity and diabetes and the pathways involved in the early oncogenic phases of PK associated with MS are not well known. The investigators hypothesize that it is possible to decipher this specific "fat-fibrosis-neoplastic sequence", to develop new imaging tools adapted to follow its progression, to test the benefit of treatments to slow this sequence and prevent the development of PK in obese and diabetic patients.This project is in line with a prevention strategy, by planning to understand the physiopathological pathways involved in MS leading to PK, to develop tools useful to screen early precancerous lesions in order to diagnose and treat patients at high risk, before cancer involvement.
This clinical trial is part of the INCA PAIR PANCREAS project : Early stages of pancreatic cancer associated with obesity and metabolic syndrome:
prevention and screening tools - Imaging of fatty pancreas in humans: correlation with pathological analysis, which includes 3 main coordinated objectives an in vitro approach an in vivo approach and this study (clinical approach).
Read the detailed description
Translational approach with direct application to humans, to test specific imaging MRI sequences in obese patients.
Obesity and metabolic syndrome are a well-known risk factor of pancreatic cancer. Obesity is associated with about 30% increased risk in all studies, but the proportion of obese people varies considerably from one country to another. Therefore, the proportion of cancer attributable to obesity could range from 3% to 16%. Numerous epidemiological studies confirmed that obesity is a risk factor of pancreatic cancer in obese men and women (BMI, kg/m2≥30.0), with a relative risk estimated to 1.76 (95% CI, 0.90-3.45) and 1.70 (95% CI, 1.09-2.64), respectively. As previously demonstrated by partners 9 and 10, obesity is associated with fat pancreatic infiltration and precancerous lesions, such as PanIN lesions in humans. Pancreatic lesions such as adipose infiltration, iron deposits, extent of fibrosis, acino-ductal metaplasia and Pan-IN are involved in pancreatic oncogenesis.
The goal of this study is to be able to diagnose early precancerous states in patients, such as acino-ductal metaplasia (and also PanIN lesions which are more frequently observed in humans,) inflammatory process (iron deposits, fibrosis lesions) and adipose involvement in the context of obesity and metabolic syndrome. Investigators hypothesis is that specific MR imaging sequences, adapted from previous studies in rodents, could be a relevant tool to diagnose early pancreatic lesions and follow their evolution in the context of obesity and metabolic syndrome.
To this aim, the investigators will conduct a study to assess the relevance of MR imaging sequences to diagnose specific pancreatic lesions in obese patients, validated at the microscopic level. The investigators will analyze MR imaging of obese patients (BMI>30)/non obese patients (BMI<25) with a planned pancreatic surgery. It will be possible to compare imaging with histology performed on resected parenchyma. The investigators propose a proof-of-concept study aiming at assessing the relevance of specific MR imaging to diagnose early pancreatic lesions in humans and in obese patients especially. MR imaging will be performed in both obese and non obese patients with a planned pancreatic surgery in hospital to resect a benign lesion (such as neuroendocrine tumour or IPMN...). MRI are performed in the normal course of care; their sequences will be adapted for this study. It will be possible to compare imaging with histology of the resected parenchyma.
- Conditions
- Pancreatic Cancer
- Being tested
- MRI with additional sequences, MRI, Left pancreatectomy or pancreaticoduodenectomy
- Keywords
- Obesity, Diabetes, metabolic syndrome, Magnetic Resonance imaging,, Pancreatic Cancer, preneoplastic lesions, acino-ductal metaplasia,
- Medical subject headings
- Pancreatic Neoplasms, Obesity, Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with additional sequencesRadiation
MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences
MRIRadiation
MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences
Left pancreatectomy or pancreaticoduodenectomyProcedure or surgery
Histological analysis :
MRI with additional sequencesRadiation
MRI with 15 min additional sequences to assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients
| Study group | Role | What they receive |
|---|---|---|
| Volunteer patient | Other | 1st stage: To adjust the transducer, test and validate pancreatic MRI sequences on volunteers without history of known pancreatic disorders. Adjustment of MRI parameters is needed to optimize data acquisition, especially in obese patients. Moreover, an external material (transducer) has to be applied on the abdomen. The right position has to be tested and specified before stages 2 and 3 of the study. We aim to include volunteers without history of known pancreatic disorders for the Stage 1, meaning volunteers without personal history or symptoms suggesting pancreatic disorders. Receives: Radiation: MRI |
| Obese volunteers with indication for hepatic MRI | Other | 2nd stage: To validate and assess pancreatic MRI sequences on obese volunteers with indication for hepatic MRI , in relation with acceptable resolution and field of view criteria applicable to the typical anteroposterior diameters found in obese persons. For Magnetic Resonance Elastography (MRE), the amplitude setting of the MRE transducer will be adapted to the size of obese patients, in addition to the aforementioned adjustments to spatial resolution and field of view sizes. The effect of frequency on MRE data quality will be investigated. The effects of respiratory motion will be investigated; indeed in obese patients respiration amplitude is typically low and this enables to acquire data in free breathing mode over long periods of time, which offers more possibilities (notably in terms of averaging, spatial resolution, mechanical wave sampling rate) than when constraining acquisition parameters with a maximum breath hold time of less than 20s. Receives: Radiation: MRI with additional sequences |
| Obese patient | Other | 3rd stage: To assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients validated at the microscopic level. We will analyze MRI of obese patients and non-obese patients with a planned pancreatic surgery. It will be possible to compare imaging with histology performed on resected parenchyma Receives: Procedure: Left pancreatectomy or pancreaticoduodenectomy; Radiation: MRI with additional sequences |
| Non obese patients | Other | 3rd stage: To assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients validated at the microscopic level. We will analyze MRI of obese patients and non-obese patients with a planned pancreatic surgery. It will be possible to compare imaging with histology performed on resected parenchyma Receives: Procedure: Left pancreatectomy or pancreaticoduodenectomy; Radiation: MRI with additional sequences |
| Overweight patients | Other | 3rd stage: To assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients validated at the microscopic level. We will analyze MRI of obese patients and non-obese patients with a planned pancreatic surgery. It will be possible to compare imaging with histology performed on resected parenchyma Receives: Procedure: Left pancreatectomy or pancreaticoduodenectomy; Radiation: MRI with additional sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative MRI parameters
Pancreatic fat content
Measured: Day 1
Quantitative MRI parameters
Diffusion coefficients (10-4 mm2/s)
Measured: Day 1
Quantitative MRI parameters
transverse magnetization relaxation rate
Measured: Day 1
Quantitative MRI parameters
longitudinal relaxation rate
Measured: Day 1
Quantitative MRI parameters
visco-elastic parameters by measure of tissue stiffness (kPa)
Measured: Day 1
fibroinflammatory lesions at histology in obese patients
% surface of fibrosis
Measured: 2 months
fibroinflammatory lesions at histology in obese patients
% surface of acinoductal metaplasia
Measured: 2 months
fibroinflammatory lesions at histology in obese patients
number of acinoductal metaplasia lesions
Measured: 2 months
Secondary outcomes (14)
Histologic parameters
% surface of fat pancreatic infiltration
Measured: 2 months
Histologic parameters
% surface of iron deposit
Measured: 2 months
Histologic parameters
% surface of fibrosis
Measured: 2 months
Histologic parameters
% surface of acinoductal metaplasia
Measured: 2 months
Histologic parameters
number of PanIN lesions
Measured: 2 months y
MRI parameters
pancreatic fat content
Measured: Day 1
MRI parameters
Diffusion coefficients (10-4 mm2/s)
Measured: Day 1
MRI parameters
transverse magnetization relaxation rate
Measured: Day 1I
MRI parameters
longitudinal magnetization relaxation rate
Measured: Day 1
MRI parameters
visco-elastic parameters by measure of tissue stiffness (kPa)
Measured: Day 1
Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma
% expression of molecules involved in TGFb and orexin signaling
Measured: 2 months
Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma
% expression of the markers in inflammatory cells (CD8, IL6, Caspase, HNF6)
Measured: 2 months
Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma
% surface of acinoductal metaplasia
Measured: 2 months
Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma
% of stained cells
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start18 Jun 2019
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: Population difficult to recruit; number of enrolled patients sufficient for analyses.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Ligue contre le cancer, France, Fondation ARC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007640
- Sponsor's protocol ID
- 2018-A02712-53
- Acronym
- PAIR-PANCREAS
- Status last verified
- Jul 2022
- First submitted
- 16 Apr 2019
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Stages of Pancreatic Cancer Associated With Obesity and Metabolic Syndrome: Prevention and Screening Tools - Imaging of Fatty Pancreas in Humans: Correlation With Pathological Analysis
- ClinicalTrials.gov ID
- NCT04007640
- Acronym / sponsor ID
- PAIR-PANCREAS / 2018-A02712-53
- Conditions
- Pancreatic Cancer
- Keywords
- Obesity, Diabetes, metabolic syndrome, Magnetic Resonance imaging,, Pancreatic Cancer, preneoplastic lesions, acino-ductal metaplasia,
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Population difficult to recruit; number of enrolled patients sufficient for analyses.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Ligue contre le cancer, France, Fondation ARC
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 Jul 2019 (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.
Obesity, diabetes and metabolic syndrome (MS) have all been associated with increase of pancreatic cancer (PK) risk. The precise role of obesity and diabetes and the pathways involved in the early oncogenic phases of PK associated with MS are not well known. The investigators hypothesize that it is possible to decipher this specific "fat-fibrosis-neoplastic sequence", to develop new imaging tools adapted to follow its progression, to test the benefit of treatments to slow this sequence and prevent the development of PK in obese and diabetic patients.This project is in line with a prevention strategy, by planning to understand the physiopathological pathways involved in MS leading to PK, to develop tools useful to screen early precancerous lesions in order to diagnose and treat patients at high risk, before cancer involvement.
This clinical trial is part of the INCA PAIR PANCREAS project : Early stages of pancreatic cancer associated with obesity and metabolic syndrome:
prevention and screening tools - Imaging of fatty pancreas in humans: correlation with pathological analysis, which includes 3 main coordinated objectives an in vitro approach an in vivo approach and this study (clinical approach).
Detailed description
Translational approach with direct application to humans, to test specific imaging MRI sequences in obese patients.
Obesity and metabolic syndrome are a well-known risk factor of pancreatic cancer. Obesity is associated with about 30% increased risk in all studies, but the proportion of obese people varies considerably from one country to another. Therefore, the proportion of cancer attributable to obesity could range from 3% to 16%. Numerous epidemiological studies confirmed that obesity is a risk factor of pancreatic cancer in obese men and women (BMI, kg/m2≥30.0), with a relative risk estimated to 1.76 (95% CI, 0.90-3.45) and 1.70 (95% CI, 1.09-2.64), respectively. As previously demonstrated by partners 9 and 10, obesity is associated with fat pancreatic infiltration and precancerous lesions, such as PanIN lesions in humans. Pancreatic lesions such as adipose infiltration, iron deposits, extent of fibrosis, acino-ductal metaplasia and Pan-IN are involved in pancreatic oncogenesis.
The goal of this study is to be able to diagnose early precancerous states in patients, such as acino-ductal metaplasia (and also PanIN lesions which are more frequently observed in humans,) inflammatory process (iron deposits, fibrosis lesions) and adipose involvement in the context of obesity and metabolic syndrome. Investigators hypothesis is that specific MR imaging sequences, adapted from previous studies in rodents, could be a relevant tool to diagnose early pancreatic lesions and follow their evolution in the context of obesity and metabolic syndrome.
To this aim, the investigators will conduct a study to assess the relevance of MR imaging sequences to diagnose specific pancreatic lesions in obese patients, validated at the microscopic level. The investigators will analyze MR imaging of obese patients (BMI>30)/non obese patients (BMI<25) with a planned pancreatic surgery. It will be possible to compare imaging with histology performed on resected parenchyma. The investigators propose a proof-of-concept study aiming at assessing the relevance of specific MR imaging to diagnose early pancreatic lesions in humans and in obese patients especially. MR imaging will be performed in both obese and non obese patients with a planned pancreatic surgery in hospital to resect a benign lesion (such as neuroendocrine tumour or IPMN...). MRI are performed in the normal course of care; their sequences will be adapted for this study. It will be possible to compare imaging with histology of the resected parenchyma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Volunteer patient | Other | Radiation: MRI1st stage: To adjust the transducer, test and validate pancreatic MRI sequences on volunteers without history of known pancreatic disorders. Adjustment of MRI parameters is needed to optimize data acquisition, especially in obese patients. Moreover, an external material (transducer) has to be applied on the abdomen. The right position has to be tested and specified before stages 2 and 3 of the study. We aim to include volunteers without history of known pancreatic disorders for the Stage 1, meaning volunteers without personal history or symptoms suggesting pancreatic disorders. |
| Obese volunteers with indication for hepatic MRI | Other | Radiation: MRI with additional sequences2nd stage: To validate and assess pancreatic MRI sequences on obese volunteers with indication for hepatic MRI , in relation with acceptable resolution and field of view criteria applicable to the typical anteroposterior diameters found in obese persons. For Magnetic Resonance Elastography (MRE), the amplitude setting of the MRE transducer will be adapted to the size of obese patients, in addition to the aforementioned adjustments to spatial resolution and field of view sizes. The effect of frequency on MRE data quality will be investigated. The effects of respiratory motion will be investigated; indeed in obese patients respiration amplitude is typically low and this enables to acquire data in free breathing mode over long periods of time, which offers more possibilities (notably in terms of averaging, spatial resolution, mechanical wave sampling rate) than when constraining acquisition parameters with a maximum breath hold time of less than 20s. |
| Obese patient | Other | Procedure: Left pancreatectomy or pancreaticoduodenectomy, Radiation: MRI with additional sequences3rd stage: To assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients validated at the microscopic level. We will analyze MRI of obese patients and non-obese patients with a planned pancreatic surgery. It will be possible to compare imaging with histology performed on resected parenchyma |
| Non obese patients | Other | Procedure: Left pancreatectomy or pancreaticoduodenectomy, Radiation: MRI with additional sequences3rd stage: To assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients validated at the microscopic level. We will analyze MRI of obese patients and non-obese patients with a planned pancreatic surgery. It will be possible to compare imaging with histology performed on resected parenchyma |
| Overweight patients | Other | Procedure: Left pancreatectomy or pancreaticoduodenectomy, Radiation: MRI with additional sequences3rd stage: To assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients validated at the microscopic level. We will analyze MRI of obese patients and non-obese patients with a planned pancreatic surgery. It will be possible to compare imaging with histology performed on resected parenchyma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1st stage : Volunteers without history of known pancreatic disorders
- 2nd stage : Obese Volunteers
- 3rd stage : Patients
Key exclusion criteria (9 listed)
- Symptoms or past medical history suggesting pancreatic disorders
- Patients with contraindication to MRI (pacemaker, claustrophobia…)
- Inability to undergo MRI due to weight excess
- Pregnant or breastfeeding woman
- Absence of free and informed consent
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 with additional sequencesMRI with 15 min additional sequences to validate and assess pancreatic MRI sequences | Radiation | Obese volunteers with indication for hepatic MRI |
| MRIMRI with 15 min additional sequences to validate and assess pancreatic MRI sequences | Radiation | Volunteer patient |
| Left pancreatectomy or pancreaticoduodenectomyHistological analysis : | Procedure or surgery | Non obese patients, Obese patient, Overweight patients |
| MRI with additional sequencesMRI with 15 min additional sequences to assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients | Radiation | Non obese patients, Obese patient, Overweight patients |
Primary outcome
Quantitative MRI parameters
Time frame: Day 1
Pancreatic fat content
Quantitative MRI parameters
Time frame: Day 1
Diffusion coefficients (10-4 mm2/s)
Quantitative MRI parameters
Time frame: Day 1
transverse magnetization relaxation rate
Quantitative MRI parameters
Time frame: Day 1
longitudinal relaxation rate
Quantitative MRI parameters
Time frame: Day 1
visco-elastic parameters by measure of tissue stiffness (kPa)
fibroinflammatory lesions at histology in obese patients
Time frame: 2 months
% surface of fibrosis
fibroinflammatory lesions at histology in obese patients
Time frame: 2 months
% surface of acinoductal metaplasia
fibroinflammatory lesions at histology in obese patients
Time frame: 2 months
number of acinoductal metaplasia lesions
14 secondary outcomes
Histologic parameters
Time frame: 2 months
Histologic parameters
Time frame: 2 months
Histologic parameters
Time frame: 2 months
Histologic parameters
Time frame: 2 months
Histologic parameters
Time frame: 2 months y
MRI parameters
Time frame: Day 1
MRI parameters
Time frame: Day 1
MRI parameters
Time frame: Day 1I
MRI parameters
Time frame: Day 1
MRI parameters
Time frame: Day 1
Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma
Time frame: 2 months
Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma
Time frame: 2 months
Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma
Time frame: 2 months
Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Population difficult to recruit; number of enrolled patients sufficient for analyses.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI with additional sequences, MRI and Left pancreatectomy or pancreaticoduodenectomy in people with Pancreatic Cancer, run by Assistance Publique - Hôpitaux de Paris 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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Aug 2026. 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 was stopped early (reason given: Population difficult to recruit; number of enrolled patients sufficient for analyses.). Results are not available in the source record.
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?
Quantitative MRI parameters (time frame: Day 1). The study lists 8 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 12 Aug 2026.