Pancreas AdenocarcinomasPADMENCT06842303
Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas
A study testing Magnetic resonance elastography (MRE). and High-resolution diffusion sequence in MRI in people with Pancreas Adenocarcinomas, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinomas
- What is being tested?
- Magnetic resonance elastography (MRE). and High-resolution diffusion sequence in MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2025to 6 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, France, 54511
DROUOT Guillaume, 0383157666, g.drouot@chru-nancy.fr
Julie LECLERC, MD
About this study
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.
- Conditions
- Pancreas Adenocarcinomas
- Being tested
- Magnetic resonance elastography (MRE)., High-resolution diffusion sequence in MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 MRIDevice
High-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images.
| Study group | Role | What they receive |
|---|---|---|
| Patient with a resectable pancreatic lesion | Experimental | Pancreatic resection surgery Receives: Device: Magnetic resonance elastography (MRE).; Device: High-resolution diffusion sequence in MRI |
| Patient with a borderline pancreatic lesion | Experimental | Potential pancreatic resection surgery after chemotherapy. Receives: Device: Magnetic resonance elastography (MRE).; Device: High-resolution diffusion sequence in MRI |
| Patient with locally advanced pancreatic lesion. | Experimental | Chemotherapy treatment. Receives: Device: Magnetic resonance elastography (MRE).; Device: High-resolution diffusion sequence in MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute elasticity value of the tumor (kPa) 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.
Measured: Baseline (J0) before treatment
Absolute elasticity value of the tumor (kPa) after chemotherapy.
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.
Measured: 3 months, after chimiotherapy
Secondary outcomes (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).
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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..
Measured: 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..
Measured: 6 months, after surgery
Overall survival in years
Time interval between the inclusion date and the date of death from any cause.
Measured: At the end of the follow-up period (maximum 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start6 Jun 2025
- Primary completion6 Jun 2027 (estimated)
- Study completion6 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas AdenocarcinomasStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LECLERC Julie, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842303
- Sponsor's protocol ID
- 2024-A01375-42
- Acronym
- PADME
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas
- ClinicalTrials.gov ID
- NCT06842303
- Acronym / sponsor ID
- PADME / 2024-A01375-42
- Conditions
- Pancreas Adenocarcinomas
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 6 Jun 2027 (estimated)
- Study completion
- 6 Jun 2027 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with a resectable pancreatic lesion | Experimental | Device: Magnetic resonance elastography (MRE)., Device: High-resolution diffusion sequence in MRIPancreatic resection surgery |
| Patient with a borderline pancreatic lesion | Experimental | Device: Magnetic resonance elastography (MRE)., Device: High-resolution diffusion sequence in MRIPotential pancreatic resection surgery after chemotherapy. |
| Patient with locally advanced pancreatic lesion. | Experimental | Device: Magnetic resonance elastography (MRE)., Device: High-resolution diffusion sequence in MRIChemotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Patient with a borderline pancreatic lesion, Patient with a resectable pancreatic lesion, Patient with locally advanced pancreatic lesion. |
| High-resolution diffusion sequence in MRIHigh-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images. | Device | Patient with a borderline pancreatic lesion, Patient with a resectable pancreatic lesion, Patient with locally advanced pancreatic lesion. |
Primary outcome
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.
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.
7 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance elastography (MRE). and High-resolution diffusion sequence in MRI in people with Pancreas Adenocarcinomas, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume DROUOT, PhD (0385157666 ext. +33, g.drouot@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute elasticity value of the tumor (kPa) before treatment. (time frame: Baseline (J0) before treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.