Predicting surgery success after chemotherapy for pancreatic cancer
Prediction of Surgical Resectability After FOLFIRINOX Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Cancer: the Role of Diffusion Weighted Magnetic Resonance Imaging, Radiomics and Liquid Biopsy
NA · University Hospital, Ghent · NCT05298722
This study is testing new ways to see if surgery can help people with pancreatic cancer after they have chemotherapy, to make sure only those who really need it go through the operation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Ghent, East Flanders and 7 other locations) |
| Trial ID | NCT05298722 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate new diagnostic tools to predict surgical resectability in patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma who receive neoadjuvant chemotherapy with FOLFIRINOX. It will utilize diffusion-weighted magnetic resonance imaging, radiomics, and liquid biopsy analyses to improve the accuracy of surgical predictions. The study will compare these innovative diagnostic methods against standard imaging techniques to identify patients who may benefit from surgery and avoid unnecessary procedures. Additionally, it will assess postoperative outcomes and survival rates.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with borderline resectable or locally advanced pancreatic ductal adenocarcinoma.
Not a fit: Patients with distant metastases or those with other types of cancer such as cholangiocarcinoma or neuroendocrine tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the ability to predict which patients are eligible for surgery, potentially increasing survival rates for pancreatic cancer.
How similar studies have performed: While individual components of this approach have shown promise, this specific combination of diagnostic tools has not been tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients, aged 18 years and above * Diagnosis of BR or LA PDAC according to NCCN guidelines (version 1.2020) * Histologic diagnosis of PDAC * No medical or anesthetic contra-indication for surgery * Able to understand nature of the study procedures * Willing to participate and give written informed consent Exclusion Criteria: * Age \< 18 years * Distant metastases * Histologic diagnosis of cholangiocarcinoma, duodenal carcinoma or neuroendocrine tumor * Known hypersensitivity for MRI contrast * Pacemaker or prosthesis with incompatibility for MRI * Claustrophobia * Pregnancy or breastfeeding * Not able to understand nature of the study procedure * Performance status ECOG score: \>2
Where this trial is running
Ghent, East Flanders and 7 other locations
- Ghent University Hospital — Ghent, East Flanders, Belgium (RECRUITING)
- AZ Sint Blasius Dendermonde — Dendermonde, Belgium (RECRUITING)
- AZ Alma Eeklo — Eeklo, Belgium (RECRUITING)
- AZ Jan Palfijn Ghent — Ghent, Belgium (RECRUITING)
- AZ Sint Lucs Ghent — Ghent, Belgium (RECRUITING)
- AZ Oudenaarde — Oudenaarde, Belgium (RECRUITING)
- AZ Vitaz Sint Niklaas - Lokeren — Sint-Niklaas, Belgium (RECRUITING)
- ZorgSaam ZH DeHonte Terneuzen — Terneuzen, Zeeland, Netherlands (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Cancer