NCT04007640

Brief 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 18, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

4.4 years

First QC Date

April 16, 2019

Last Update Submit

July 7, 2022

Conditions

Pancreatic Cancer

Keywords

ObesityDiabetesmetabolic syndromeMagnetic Resonance imaging,Pancreatic Cancerpreneoplastic lesionsacino-ductal metaplasia,

Outcome Measures

Primary Outcomes (8)

  • Quantitative MRI parameters

    Pancreatic fat content

    Day 1

  • Quantitative MRI parameters

    Diffusion coefficients (10-4 mm2/s)

    Day 1

  • Quantitative MRI parameters

    transverse magnetization relaxation rate

    Day 1

  • Quantitative MRI parameters

    longitudinal relaxation rate

    Day 1

  • Quantitative MRI parameters

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

    Day 1

  • fibroinflammatory lesions at histology in obese patients

    % surface of fibrosis

    2 months

  • fibroinflammatory lesions at histology in obese patients

    % surface of acinoductal metaplasia

    2 months

  • fibroinflammatory lesions at histology in obese patients

    number of acinoductal metaplasia lesions

    2 months

Secondary Outcomes (14)

  • Histologic parameters

    2 months

  • Histologic parameters

    2 months

  • Histologic parameters

    2 months

  • Histologic parameters

    2 months

  • Histologic parameters

    2 months y

  • +9 more secondary outcomes

Study Arms (5)

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.

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.

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

Procedure: Left pancreatectomy or pancreaticoduodenectomyRadiation: 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

Procedure: Left pancreatectomy or pancreaticoduodenectomyRadiation: 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

Procedure: Left pancreatectomy or pancreaticoduodenectomyRadiation: MRI with additional sequences

Interventions

MRI with additional sequencesRADIATION

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

Obese volunteers with indication for hepatic MRI
MRIRADIATION

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

Volunteer patient
Left pancreatectomy or pancreaticoduodenectomyPROCEDURE

Histological analysis :

Non obese patientsObese patientOverweight patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • st stage : Volunteers without history of known pancreatic disorders
  • \- Adults
  • nd stage : Obese Volunteers
  • Adults with planned hepatic MRI
  • Obese (BMI ≥30)
  • rd 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Beaujon

Clichy, France

NOT YET RECRUITING

Hôpital Beaujon

Clichy, France

RECRUITING

MeSH Terms

Conditions

Pancreatic NeoplasmsObesityDiabetes MellitusMetabolic Syndrome

Interventions

Magnetic Resonance SpectroscopyPancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesInsulin ResistanceHyperinsulinism

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDigestive System Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Anne COUVELARD, MD

CONTACT

140258012anne.couvelard@aphp.fr

Vincianne REBOURS, MD

CONTACT

140875215vincianne.rebours@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

July 5, 2019

Study Start

June 18, 2019

Primary Completion

October 27, 2023

Study Completion

October 27, 2023

Last Updated

July 8, 2022

Record last verified: 2022-07

Locations

FR(2)