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

NCT05249075 | Active Not Recruiting

• 1 other identifier: 112922
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Ability to perform genetic sequencing on the sample

  2 years

• Puncture success rate

  2 years

• User experience

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• years and older
• Clinical suspicion of pancreatic adenocarcinoma
• Indication for obtaining EUS-guided histology of a suspected pancreatic lesion
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Erwin van Geenen, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: March 1, 2022
• Primary Completion: August 14, 2025
• Study Completion: December 1, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

NL (1)