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NCT Number: NCT05249075

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

About this study

This study is an international multicenter prospective cohort study. The study will be performed in collaboration with the disciplines of Gastroenterology and Pathology of the participating hospitals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy of the Micro-Tech FNB needle in obtaining pancreatic malignancy

    Time frame: 2 years

    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.

Secondary outcomes

  1. Ability to perform genetic sequencing on the sample

    Time frame: 2 years

    Pathologist will analyze the obtained specimen and determines the size and tumor cellularity. The specimen is deemed sufficient for performing genetic sequencing when tumor cellularity is >20% and the surface is >5mm2. At this stage, no genetic sequencing will be performed

  2. Puncture success rate

    Time frame: 2 years

    Puncture is successful if the pathologist is able to make a diagnosis on the obtained specimen. By putting each biopsy in a different formalin jar, we can count how many biopsies are needed to be taken to obtain a representative biopsy for diagnosis.

  3. User experience

    Time frame: 2 years

    User experience of performing FNB with this needle scored with a questionnaire filled in by each participating gastroenterologist after performing all procedures.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: MT-FNB

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2022
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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