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Trial Title:
Precision Imaging for Early Detection and Targeted Treatment Monitoring in Pancreatic Cancer
NCT ID:
NCT06144762
Condition:
Pancreas Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Radiomics
Ovarian cancer
Genomics
Proteomics
Immune Tumor Microenvironment
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Biological/Vaccine: Blood sample and tissue sample
Description:
During the surgery :
Tissus sample : primary tumor and metastasis blood sample : 3 EDTA tubes ex vivo MRI data
Arm group label:
Blood sample and tissue sample
Summary:
Specifically, in this project, the objective will be developped a model to capture
imaging-based tumor heterogeneity with multiscale radiomics approach by obtaining the
mirror tumor image at in vivo MRI, ex vivo MRI at histology. This imaging model giving a
perfect virtual histology tumor representation will be secondary implemented on routine
in vivo clinical MRI for early cancer detection and treatment monitoring. Successful
completion of this proposal will lead to a comprehensive non invasive characterisation of
pancreatic cancer and will be a game changer in patient management.
Detailed description:
With a five-year survival rate of only 3% for the majority of patients, pancreatic cancer
is a global healthcare challenge. By the time of diagnosis over half of pancreatic
cancers are metastasized. The dire disease situation reflects our inability to diagnose
pancreatic cancer early and to effectively treat it. Our failure to diagnose the disease
early results in part from the inaccessibility of the organ, difficulties in detecting
small pancreatic lesions by conventional imaging approaches, and a poor understanding of
the spectrum of heterogeneity in pancreatic cancer. Single time point, single site
biopsies cannot assess entire tumor while multiple biopsies at several time points are
not feasible in clinical routine. Limitations of invasive sampling may be addressed with
non-invasive imaging that captures morphologic and functional information about the
entire tumor in space and, if repeated, in time. Radiomics has the potential for "whole
tumour virtual sampling" using a single or serial non-invasive examinations in place of
biopsies. By approaching images as data able to be mined, instead of merely pictures in
conventional radiology, quantitative imaging allows for further information to be
extracted from medical images as well as for global assessments across large patient
populations. Therefore, these new quantitative approaches hold the promise of detecting
pancreatic cancer characteristics that the naked eye alone cannot perceive from
conventional medical imaging, opening new doors for personalized medicine in pancreatic
cancer. To date, no study has evaluated the value of radiomics at macroscopic (in vivo
1.5T/3TMRI) and microscopic (ex vivo 9.4TMRI) scale for early cancer detection and
targeted treatment monitoring. Specifically, in this project, the objective will be
developpe a model to capture imaging-based tumor heterogeneity with multiscale radiomics
approach by obtaining the mirror tumor image at in vivo MRI, ex vivo MRI at histology.
This imaging model giving a perfect virtual histology tumor representation will be
secondary implemented on routine in vivo clinical MRI for early cancer detection and
treatment monitoring. Successful completion of this proposal will lead to a comprehensive
non invasive characterisation of pancreatic cancer and will be a game changer in patient
management.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient aged >18 2.
- Pathologically proven pancreatic cancer which can beneficiate of upfront surgery or
delayed surgery followed by neoadjuvant chemotherapy.
- Negative pregnancy test for women of childbearing potential
- Patients affiliated to a social protection system
- Written informed consent signed before project onset.
Exclusion Criteria:
- presence of metastases,
- Patient who will not have surgery
- Pregnant or breastfeeding women
- Mental or psychological state, physical or legal incapacity preventing participation
in the project.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NOUGARET Stephanie
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Contact:
Last name:
NOUGARET Stephanie, MD
Email:
stephanie.nougaret@icm.unicancer.fr
Start date:
December 19, 2023
Completion date:
October 2029
Lead sponsor:
Agency:
Institut du Cancer de Montpellier - Val d'Aurelle
Agency class:
Other
Source:
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06144762