Using a new needle to collect tissue samples for pancreatic cancer treatment
Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy
This study is testing a new type of needle to see if it can help doctors get better tissue samples from patients suspected of having pancreatic cancer, which could lead to more personalized treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT05249075 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the diagnostic accuracy of a new fine needle biopsy (FNB) technique for obtaining tissue specimens from patients suspected of having pancreatic cancer. By collecting high-quality tumor samples through endoscopic ultrasound (EUS), the study seeks to improve the reliability of diagnoses and enable personalized chemotherapy regimens based on genomic profiling. The study will be conducted as an international multicenter prospective cohort study, involving collaboration between gastroenterology and pathology departments at participating hospitals. The focus is on ensuring sufficient and accurate tissue collection to facilitate advanced treatment options for patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical suspicion of pancreatic adenocarcinoma who require EUS-guided histology.
Not a fit: Patients with contraindications to EUS or those who cannot understand the patient information due to language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and tailored chemotherapy treatments for pancreatic cancer patients.
How similar studies have performed: While the approach of using FNB for tissue collection is established, this specific evaluation of a new FNB needle's diagnostic accuracy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older * Clinical suspicion of pancreatic adenocarcinoma * Indication for obtaining EUS-guided histology of a suspected pancreatic lesion * Written informed consent Exclusion Criteria: * Contra-indications to undergoing an EUS (e.g., oropharyngeal abnormalities) * Altered anatomy (e.g., after previous Whipple-operation, Roux-and-Y gastrojejunostomy) * Contra-indications to the administration of benzodiazepines, propophol or opioids * Pregnancy * Insufficient knowledge of the Dutch language to be able to understand the patient information
Where this trial is running
Nijmegen, Gelderland
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Erwin van Geenen, MD, PhD — Radboud University Medical Center
- Study coordinator: Mike de Jong, MD
- Email: mike.dejong@radboudumc.nl
- Phone: 0031883207054
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.