Contribution Of New Pancreatic MRI Sequences For The Evaluation Of Tumor Response In Pancreatic Adenocarcinomas

Study Overview

Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas

Pancreatic adenocarcinoma is the most pessimistic digestive cancer in terms of prognosis. Tumor response assessment is crucial, and the recent development of new magnetic resonance imaging sequences, such as high resolution applied to diffusion sequences (Harder et al., 2022) or magnetic resonance elastography (MRE) (Steinkohl et al., 2021), could help address this issue.

N/A

Pancreas Adenocarcinomas

DEVICE: Magnetic resonance elastography (MRE).
DEVICE: High-resolution diffusion sequence in MRI

2024-A01375-42

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-02-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-16
First Submitted that Met QC Criteria 2025-02-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-17
First Posted (ACTUAL) 2025-02-24	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Patient with a resectable pancreatic lesion Pancreatic resection surgery	DEVICE: Magnetic resonance elastography (MRE). Magnetic resonance elastography (MRE) is an imaging technique that measures tissue stiffness by assessing the deformation waves produced under external pressure DEVICE: High-resolution diffusion sequence in MRI High-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images.
EXPERIMENTAL: Patient with a borderline pancreatic lesion Potential pancreatic resection surgery after chemotherapy.	DEVICE: Magnetic resonance elastography (MRE). Magnetic resonance elastography (MRE) is an imaging technique that measures tissue stiffness by assessing the deformation waves produced under external pressure DEVICE: High-resolution diffusion sequence in MRI High-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images.
EXPERIMENTAL: Patient with locally advanced pancreatic lesion. Chemotherapy treatment.	DEVICE: Magnetic resonance elastography (MRE). Magnetic resonance elastography (MRE) is an imaging technique that measures tissue stiffness by assessing the deformation waves produced under external pressure DEVICE: High-resolution diffusion sequence in MRI High-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Patient with a resectable pancreatic lesion

Pancreatic resection surgery

DEVICE: Magnetic resonance elastography (MRE).

Magnetic resonance elastography (MRE) is an imaging technique that measures tissue stiffness by assessing the deformation waves produced under external pressure

DEVICE: High-resolution diffusion sequence in MRI

High-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images.

EXPERIMENTAL: Patient with a borderline pancreatic lesion

Potential pancreatic resection surgery after chemotherapy.

DEVICE: Magnetic resonance elastography (MRE).

Magnetic resonance elastography (MRE) is an imaging technique that measures tissue stiffness by assessing the deformation waves produced under external pressure

DEVICE: High-resolution diffusion sequence in MRI

High-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images.

EXPERIMENTAL: Patient with locally advanced pancreatic lesion.

Chemotherapy treatment.

DEVICE: Magnetic resonance elastography (MRE).

Magnetic resonance elastography (MRE) is an imaging technique that measures tissue stiffness by assessing the deformation waves produced under external pressure

DEVICE: High-resolution diffusion sequence in MRI

High-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images.

Primary Outcome Measures	Measure Description	Time Frame
Absolute elasticity value of the tumor (kPa) before treatment.	The absolute elasticity value of the tumor corresponds to the average elasticity value measured within the region of interest, which will be outlined according to the tumor's boundaries.	Baseline (J0) before treatment
Absolute elasticity value of the tumor (kPa) after chemotherapy.	The absolute elasticity value of the tumor corresponds to the average elasticity value measured within the region of interest, which will be outlined according to the tumor's boundaries.	3 months, after chimiotherapy

Secondary Outcome Measures	Measure Description	Time Frame
For patient with a resectable pancreatic lesion, evaluation of the association between size of the tumor (mm) with the absolute elasticity value of the tumor (kPa).		3 months, after surgery
For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the absolute elasticity value of the tumor (kPa) before chimiotherapy.		6 months, after surgery
For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the absolute elasticity value of the tumor (kPa) after chimiotherapy..		6 months, after surgery
For patient with a resectable pancreatic lesion, evaluation of the association between size of the tumor (mm) with the apparent coefficient diffusion (ADC) in mm²/s.		3 months, after surgery
For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) with the apparent coefficient diffusion (ADC) in mm²/s before chimiotherapy..		6 months, after surgery
For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the apparent coefficient diffusion (ADC) in mm²/s after chimiotherapy..		6 months, after surgery
Overall survival in years	Time interval between the inclusion date and the date of death from any cause.	At the end of the follow-up period (maximum 24 months).

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Guillaume DROUOT, PhD

Phone Number: 0385157666

Email: g.drouot@chru-nancy.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

CT scan diagnosis of non-metastatic pancreatic cancer on contrast-enhanced thoraco-abdomino-pelvic CT;
Adult patient: age ≥ 18 years;
Patient affiliated with a social security system or beneficiary of such a system;
Patient who has received complete information about the research organization and has signed an informed consent form.

Patient with a contraindication to MRI.
Person referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code.

Pregnant woman, parturient, or breastfeeding mother;
Minor (non-emancipated) individual;
Adult individual under legal protection (guardianship, curatorship, or judicial safeguard);
Adult individual unable to express consent.
Person deprived of liberty by a judicial or administrative decision, or person undergoing psychiatric care pursuant to Articles L. 32-12-1 and L. 3213-1 of the French Public Health Code.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record