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OpenTrials
Terminated

NCT Number: NCT04007640

Early Screening of Pancreatic Lesions : Development of New Imaging Tools

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).

Why the study stopped: Population difficult to recruit; number of enrolled patients sufficient for analyses.
Terminated

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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), overweight (25≤BMI≤29.9) or non-obese patients (18.5<BMI<24.9)

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

Treatment and study plan

MRI with additional sequences

Radiation

MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences

MRI

Radiation

MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences

Left pancreatectomy or pancreaticoduodenectomy

Procedure

Histological analysis :

Primary outcomes

  1. Quantitative MRI parameters

    Time frame: Day 1

    Pancreatic fat content

  2. Quantitative MRI parameters

    Time frame: Day 1

    Diffusion coefficients (10-4 mm2/s)

  3. Quantitative MRI parameters

    Time frame: Day 1

    transverse magnetization relaxation rate

  4. Quantitative MRI parameters

    Time frame: Day 1

    longitudinal relaxation rate

  5. Quantitative MRI parameters

    Time frame: Day 1

    visco-elastic parameters by measure of tissue stiffness (kPa)

  6. fibroinflammatory lesions at histology in obese patients

    Time frame: 2 months

    % surface of fibrosis

  7. fibroinflammatory lesions at histology in obese patients

    Time frame: 2 months

    % surface of acinoductal metaplasia

  8. fibroinflammatory lesions at histology in obese patients

    Time frame: 2 months

    number of acinoductal metaplasia lesions

Secondary outcomes

  1. Histologic parameters

    Time frame: 2 months

    % surface of fat pancreatic infiltration

  2. Histologic parameters

    Time frame: 2 months

    % surface of iron deposit

  3. Histologic parameters

    Time frame: 2 months

    % surface of fibrosis

  4. Histologic parameters

    Time frame: 2 months

    % surface of acinoductal metaplasia

  5. Histologic parameters

    Time frame: 2 months y

    number of PanIN lesions

  6. MRI parameters

    Time frame: Day 1

    pancreatic fat content

  7. MRI parameters

    Time frame: Day 1

    Diffusion coefficients (10-4 mm2/s)

  8. MRI parameters

    Time frame: Day 1I

    transverse magnetization relaxation rate

  9. MRI parameters

    Time frame: Day 1

    longitudinal magnetization relaxation rate

  10. MRI parameters

    Time frame: Day 1

    visco-elastic parameters by measure of tissue stiffness (kPa)

  11. Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma

    Time frame: 2 months

    % expression of molecules involved in TGFb and orexin signaling

  12. Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma

    Time frame: 2 months

    % expression of the markers in inflammatory cells (CD8, IL6, Caspase, HNF6)

  13. Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma

    Time frame: 2 months

    % surface of acinoductal metaplasia

  14. Biomarkers of pathways activation measured by immunohistochemistry on resected pancreatic parenchyma

    Time frame: 2 months

    % of stained cells

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation ARC
  • Ligue contre le cancer, France
  • National Cancer Institute, France

Registry information

Official study 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

Acronym: PAIR-PANCREAS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2019
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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