Pancreatic CancerMT-FNBNCT05249075
Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy
An observational study of Pancreatic Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 138 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2022to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years and older
- Clinical suspicion of pancreatic adenocarcinoma
- Indication for obtaining EUS-guided histology of a suspected pancreatic lesion
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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
Measured: 2 years
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.
Measured: 2 years
User experience
User experience of performing FNB with this needle scored with a questionnaire filled in by each participating gastroenterologist after performing all procedures.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Mar 2022
- Primary completion14 Aug 2025
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwin van Geenen, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249075
- Sponsor's protocol ID
- 112922
- Acronym
- MT-FNB
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The dataset used during this study is available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy
- ClinicalTrials.gov ID
- NCT05249075
- Acronym / sponsor ID
- MT-FNB / 112922
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 18 years and older
- Clinical suspicion of pancreatic adenocarcinoma
- Indication for obtaining EUS-guided histology of a suspected pancreatic lesion
- Written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Ability to perform genetic sequencing on the sample
Time frame: 2 years
Puncture success rate
Time frame: 2 years
User experience
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Undecided. The dataset used during this study is available from the corresponding author upon reasonable request.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwin van Geenen, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the Micro-Tech FNB needle in obtaining pancreatic malignancy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.