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

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Pancreas Adenocarcinomas

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06842303

2024-A01375-42

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Patient with a resectable pancreatic lesion

Experimental group

Description:

Pancreatic resection surgery

Treatment:

Device: Magnetic resonance elastography (MRE).

Device: High-resolution diffusion sequence in MRI

Patient with a borderline pancreatic lesion

Experimental group

Description:

Potential pancreatic resection surgery after chemotherapy.

Treatment:

Device: Magnetic resonance elastography (MRE).

Device: High-resolution diffusion sequence in MRI

Patient with locally advanced pancreatic lesion.

Experimental group

Description:

Chemotherapy treatment.

Treatment:

Device: Magnetic resonance elastography (MRE).

Device: High-resolution diffusion sequence in MRI