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

NCT06842303 | Recruiting

• 1 other identifier: 2024-A01375-42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreas Adenocarcinomas

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (3)

Patient with a resectable pancreatic lesion

EXPERIMENTAL

Pancreatic resection surgery

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

Patient with a borderline pancreatic lesion

EXPERIMENTAL

Potential pancreatic resection surgery after chemotherapy.

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

Patient with locally advanced pancreatic lesion.

EXPERIMENTAL

Chemotherapy treatment.

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

Interventions

Magnetic resonance elastography (MRE). DEVICE

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

Patient with a borderline pancreatic lesion; Patient with a resectable pancreatic lesion; Patient with locally advanced pancreatic lesion.

High-resolution diffusion sequence in MRI DEVICE

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

Patient with a borderline pancreatic lesion; Patient with a resectable pancreatic lesion; Patient with locally advanced pancreatic lesion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, France, 54511, France

RECRUITING

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Guillaume DROUOT, PhD

CONTACT

0385157666; g.drouot@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 24, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): June 6, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)