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NCT05249075

Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

Summary

Systemic chemotherapy can improve disease-related symptoms and/or prolong survival in patients with pancreatic cancer. Before the start of chemotherapy, the diagnosis pancreatic carcinoma must be confirmed by tumor tissue samples, which are often obtained during endoscopic ultrasound (EUS) by fine needle aspiration (FNA) or fine needle biopsy (FNB). Obtaining core biopsies by FNB has several potential benefits, such as making a more reliable diagnosis, performing immunohistochemistry for diagnostic reasons and in the future obtaining enough malignant cells to deliver personalized based chemotherapy regimen based on mutations detected by next generation sequencing. Obtaining high quality and sufficient tumor material is essential for genomic profiling with a preference of FNB over FNA. Up to now, no specific FNB needle has been found to be superior in diagnostic accuracy and in obtaining tissue for genomic profiling. In this study, we aim to evaluate the diagnostic accuracy of a new FNB needle (Micro-Tech Europe GmbH, Düsseldorf, Germany) and we study the adequacy of the obtained tissue samples for performing genetic sequencing.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2022-03-01

Completion Date

2025-12-01

Last Updated

2025-08-21

Healthy Volunteers

No

Locations (1)

Radboudumc

Nijmegen, Gelderland, Netherlands