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Recruiting NCT06842303

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

No phase Interventional Pancreas Adenocarcinomas

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic resonance elastography (MRE)., High-resolution diffusion sequence in MRI.
Who it may be relevant to
Registry conditions: Pancreas Adenocarcinomas. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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

  • Absolute elasticity value of the tumor (kPa) before treatment. [Time frame: Baseline (J0) before treatment]
  • Absolute elasticity value of the tumor (kPa) after chemotherapy. [Time frame: 3 months, after chimiotherapy]
Secondary outcome measures (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). [Time frame: 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. [Time frame: 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.. [Time frame: 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. [Time frame: 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.. [Time frame: 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.. [Time frame: 6 months, after surgery]
  • Overall survival in years [Time frame: At the end of the follow-up period (maximum 24 months).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHRU Nancy — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT06842303 · 2024-A01375-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗