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

Pancreatic Cancer Clinical Trial

— MT-FNB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249075
• Other study ID #: 112922
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Radboud University Medical Center
• Contact: Mike de Jong, MD
• Phone: 0031883207054
• Email: mike.dejong[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ability to perform genetic sequencing on the sample	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 years
Secondary	Puncture success rate	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.	2 years
Secondary	User experience	User experience of performing FNB with this needle scored with a questionnaire filled in by each participating gastroenterologist after performing all procedures.	2 years