Clinical trial NCT06842303: Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas
Official title: Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreas Adenocarcinomas
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Absolute elasticity value of the tumor (kPa) before treatment.
timeFrame: Baseline (J0) before treatment
measure: Absolute elasticity value of the tumor (kPa) after chemotherapy.
timeFrame: 3 months, after chimiotherapy
Secondary outcomes:
measure: 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).
timeFrame: 3 months, after surgery
measure: 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.
timeFrame: 6 months, after surgery
measure: 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..
timeFrame: 6 months, after surgery
measure: 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.
timeFrame: 3 months, after surgery
measure: 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..
timeFrame: 6 months, after surgery
measure: 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..
timeFrame: 6 months, after surgery
measure: Overall survival in years
timeFrame: At the end of the follow-up period (maximum 24 months).
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: CHRU Nancy
Study officials:
References: