Early Screening of Pancreatic Lesions : Development of New Imaging Tools
NCT ID: NCT04007640
Last Updated: 2022-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
59 participants
INTERVENTIONAL
2019-06-18
2023-10-27
Brief Summary
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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).
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Volunteer patient
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.
MRI
MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences
Obese volunteers with indication for hepatic MRI
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.
MRI with additional sequences
MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences
Obese patient
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
Left pancreatectomy or pancreaticoduodenectomy
Histological analysis :
MRI with additional sequences
MRI with 15 min additional sequences to assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients
Non obese patients
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
Left pancreatectomy or pancreaticoduodenectomy
Histological analysis :
MRI with additional sequences
MRI with 15 min additional sequences to assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients
Overweight patients
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
Left pancreatectomy or pancreaticoduodenectomy
Histological analysis :
MRI with additional sequences
MRI with 15 min additional sequences to assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients
Interventions
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MRI with additional sequences
MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences
MRI
MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences
Left pancreatectomy or pancreaticoduodenectomy
Histological analysis :
MRI with additional sequences
MRI with 15 min additional sequences to assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients
Eligibility Criteria
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Inclusion Criteria
\- 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)
Exclusion Criteria
\- 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
* 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
18 Years
ALL
Yes
Sponsors
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National Cancer Institute, France
OTHER_GOV
Ligue contre le cancer, France
OTHER
Fondation ARC
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Hôpital Beaujon
Clichy, , France
Hôpital Beaujon
Clichy, , France
Countries
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Central Contacts
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Facility Contacts
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Valérie VILGRAIN, MD
Role: primary
Other Identifiers
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2018-A02712-53
Identifier Type: -
Identifier Source: org_study_id
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