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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 (PeRFormanCe Trial)

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Ghent
NCT05298722 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In this prospective study, new diagnostic tools will be explored for patients with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (BR or LAPDA) who undergo neoadjuvant chemotherapy with FOLFIRINOX. The diagnostic work-up and therapy for the study population will not differ from the gold standard during the study; only additional diagnostic tools will be implemented, and their value will be analyzed post hoc. The 5-year survival rate of pancreatic cancer is 9%, but this can be drastically improved if surgery is possible. With its increasing incidence and poor prognosis, pancreatic cancer is becoming a global oncologic challenge where major breakthroughs are still required to improve patient outcomes. Patients with BR or LAPDA typically undergo neoadjuvant treatment with FOLFIRINOX chemotherapy, followed by referral for surgery if a response is observed. In th

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📋 Eligibility rules (as published)
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
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What it tests

  • Imaging analysis of CT-scan and MRI with radiomics and genetic analysis of peripheral blood samples and questionnaires.
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Where

8 sites
Ghent University Hospital
Ghent, Belgium
AZ Sint Blasius Dendermonde
Dendermonde, Belgium
AZ Alma Eeklo
Eeklo, Belgium
AZ Jan Palfijn Ghent
Ghent, Belgium
AZ Sint Lucs Ghent
Ghent, Belgium
AZ Oudenaarde
Oudenaarde, Belgium
AZ Vitaz Sint Niklaas - Lokeren
Sint-Niklaas, Belgium
ZorgSaam ZH DeHonte Terneuzen
Terneuzen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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