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NCT Number: NCT06842303

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.

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Key information

Conditions

Pancreas Adenocarcinomas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Nancy

Vandœuvre-lès-Nancy, France, 54511

Location status: Recruiting

Location contact

DROUOT Guillaume

CONTACT

[email protected]

0383157666

Julie LECLERC, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Absolute elasticity value of the tumor (kPa) before treatment.

    Time frame: Baseline (J0) 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.

  2. Absolute elasticity value of the tumor (kPa) after chemotherapy.

    Time frame: 3 months, after chimiotherapy

    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.

Secondary outcomes

  1. 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).

    Time frame: 3 months, after surgery

  2. 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.

    Time frame: 6 months, after surgery

  3. 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..

    Time frame: 6 months, after surgery

  4. 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.

    Time frame: 3 months, after surgery

  5. 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..

    Time frame: 6 months, after surgery

  6. 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..

    Time frame: 6 months, after surgery

  7. Overall survival in years

    Time frame: At the end of the follow-up period (maximum 24 months).

    Time interval between the inclusion date and the date of death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume DROUOT, PhD

CONTACT

[email protected]

0385157666 ext. +33

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: PADME

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2025
Registry last updated
Jul 17, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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