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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreas Adenocarcinomas
• Intervention / Treatment: Device: Magnetic resonance elastography (MRE).; Device: High-resolution diffusion sequence in MRI

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume DROUOT, PhD; Phone Number: +33 0385157666; Email: g.drouot@chru-nancy.fr

Study Locations

• France
  • Vandoeuvre-lès-Nancy, France, 54511
    • Recruiting
    • CHRU Nancy
    • Contact: DROUOT Guillaume; Phone Number: 0383157666; Email: g.drouot@chru-nancy.fr
    • Principal Investigator: Julie LECLERC, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): June 6, 2027

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: 2024-A01375-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No