Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy
MT-FNB
MT-FNB
Sponsor study identifier
observational
138
1 country
1
Study Start
March 1, 2022
Actual (reported)Primary Completion
August 14, 2025
Actual (reported)Study Completion
July 1, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 10, 2022
Actual (reported)February 21, 2022
Actual (reported)March 1, 2022
Actual (reported)August 14, 2025
Actual (reported)July 1, 2026
Actual (reported)Diagnostic accuracy of the Micro-Tech FNB needle in obtaining pancreatic malignancy
Pathologist scores the obtained specimen according the Bethesda system. Diagnostic accuracy will be quantified by the sensitivity and specificity and expressed as frequency of pancreatic malignancy as confirmed by histological evaluation.
2 years
Ability to perform genetic sequencing on the sample
2 years
Puncture success rate
2 years
User experience
2 years
Each patient with clinical suspicion of pancreatic cancer, based on imaging, will be discussed in the multidisciplinary team consultation. When an EUS-FNB is indicated, patients are included if they meet all the inclusion and none of the exclusion criteria. The population will consist of elderly patients, as pancreatic cancer is rarely diagnosed before the age of 55.
Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
Erwin van Geenen, MD, PhD
Radboud University Medical Center
138 participants (actual enrollment reported by the registry).
First Submitted
February 10, 2022
First Posted
February 21, 2022
Study Start
March 1, 2022
Actual (reported)CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer
Contact the study team to confirm eligibility.
Primary Completion
August 14, 2025
Actual (reported)Study Completion
July 1, 2026
Actual (reported)Last Updated
August 21, 2026
Record last verified: 2026-08
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