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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

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