Early Screening of Pancreatic Lesions : Development of New Imaging Tools
Клучни зборови
Апстракт
Опис
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.
Датуми
| Последен пат проверено: | 08/31/2019 |
| Прво доставено: | 04/15/2019 |
| Поднесено е проценето запишување: | 06/30/2019 |
| Прво објавено: | 07/04/2019 |
| Последното ажурирање е доставено: | 09/16/2019 |
| Последно ажурирање објавено: | 09/17/2019 |
| Крај на датумот на започнување на студијата: | 06/17/2019 |
| Проценет датум на примарно завршување: | 05/31/2022 |
| Проценет датум на завршување на студијата: | 09/30/2022 |
Состојба или болест
Интервенција / третман
Radiation: Obese volunteers with indication for hepatic MRI
Radiation: Volunteer patient
Procedure: Left pancreatectomy or pancreaticoduodenectomy
Radiation: MRI with additional sequences
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Other: 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. | Radiation: Volunteer patient MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences |
| Other: 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. | Radiation: Obese volunteers with indication for hepatic MRI MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences |
| Other: 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 | |
| Other: 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 |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | Inclusion Criteria: - 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) or non-obese patients (18.5 Exclusion Criteria: 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 - 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 |
Исход
Мерки на примарниот исход
1. Quantitative MRI parameters [Day 1]
2. Quantitative MRI parameters [Day 1]
3. Quantitative MRI parameters [Day 1]
4. Quantitative MRI parameters [Day 1]
5. Quantitative MRI parameters [Day 1]
6. fibroinflammatory lesions at histology in obese patients [2 months]
7. fibroinflammatory lesions at histology in obese patients [2 months]
8. fibroinflammatory lesions at histology in obese patients [2 months]
Секундарни мерки на исходот
1. Histologic parameters [2 months]
2. Histologic parameters [2 months]
3. Histologic parameters [2 months]
4. Histologic parameters [2 months]
5. Histologic parameters [2 months y]
6. MRI parameters [Day 1]
7. MRI parameters [Day 1]
8. MRI parameters [Day 1I]
9. MRI parameters [Day 1]
10. MRI parameters [Day 1]
11. Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma [2 months]
12. Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma [2 months]
13. Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma [2 months]
14. Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma [2 months]
