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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06842303
Acronym
PADME
Enrollment
120
Registered
2025-02-24
Start date
2025-06-06
Completion date
2027-06-06
Last updated
2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Adenocarcinomas

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.

Interventions

DEVICEMagnetic resonance elastography (MRE).

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

DEVICEHigh-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.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Absolute elasticity value of the tumor (kPa) before treatment.Baseline (J0) before treatmentThe 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.
Absolute elasticity value of the tumor (kPa) after chemotherapy.3 months, after chimiotherapyThe 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

MeasureTime frameDescription
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 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 apparent coefficient diffusion (ADC) in mm²/s after chimiotherapy..6 months, after surgery
Overall survival in yearsAt the end of the follow-up period (maximum 24 months).Time interval between the inclusion date and the date of death from any cause.
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
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

Countries

France

Contacts

Primary ContactGuillaume DROUOT, PhD
g.drouot@chru-nancy.fr0385157666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026