Pancreatic CancerNCT02678442
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
A study testing Fine Needle Biopsy (FNB) and Fine Needle Aspiration (FNA) in people with Pancreatic Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Fine Needle Biopsy (FNB) and Fine Needle Aspiration (FNA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2016to 10 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion.
- International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,000.
- Medically stable to undergo sedation for EUS.
- Signed informed consent
Who cannot join
- Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
Read the detailed description
This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.
- Conditions
- Pancreatic Cancer
- Being tested
- Fine Needle Biopsy (FNB), Fine Needle Aspiration (FNA)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine Needle Biopsy (FNB)Device
Also called Shark Core Fine Needle Biopsy
The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
Fine Needle Aspiration (FNA)Device
Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| FNB first, then FNA | Active comparator | In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA). Receives: Device: Fine Needle Biopsy (FNB); Device: Fine Needle Aspiration (FNA) |
| FNA first, then FNB | Active comparator | In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB). Receives: Device: Fine Needle Biopsy (FNB); Device: Fine Needle Aspiration (FNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total DNA Yield of Adenocarcinoma
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
Measured: Baseline
Secondary outcomes (6)
Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis
The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.
Measured: Baseline
Core Tissue Length
The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.
Measured: Baseline
Concentration of DNA Yield of Adenocarcinoma
The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.
Measured: Baseline
Percentage of Tumor Cellularity
Percent of tumor cellularity with first pass of adenocarcinoma
Measured: Baseline
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation
The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.
Measured: Baseline
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation
The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start16 May 2016
- Primary completion10 Nov 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Michael Wallace, Mayo Clinic
- Investigators
- Michael B. Wallace, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678442
- Sponsor's protocol ID
- 15-007801
- Status last verified
- Dec 2019
- First submitted
- 5 Feb 2016
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
- ClinicalTrials.gov ID
- NCT02678442
- Acronym / sponsor ID
- 15-007801
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 16 May 2016
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
Detailed description
This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FNB first, then FNA | Active comparator | Device: Fine Needle Biopsy (FNB), Device: Fine Needle Aspiration (FNA)In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA). |
| FNA first, then FNB | Active comparator | Device: Fine Needle Biopsy (FNB), Device: Fine Needle Aspiration (FNA)In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion.
- International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,000.
- Medically stable to undergo sedation for EUS.
- Signed informed consent
Key exclusion criteria (2 listed)
- Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fine Needle Biopsy (FNB)Also: Shark Core Fine Needle BiopsyThe Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites. | Device | FNA first, then FNB, FNB first, then FNA |
| Fine Needle Aspiration (FNA)Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds. | Device | FNA first, then FNB, FNB first, then FNA |
Primary outcome
Total DNA Yield of Adenocarcinoma
Time frame: Baseline
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
6 secondary outcomes
Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis
Time frame: Baseline
Core Tissue Length
Time frame: Baseline
Concentration of DNA Yield of Adenocarcinoma
Time frame: Baseline
Percentage of Tumor Cellularity
Time frame: Baseline
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation
Time frame: Baseline
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael B. Wallace, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fine Needle Biopsy (FNB) and Fine Needle Aspiration (FNA) in people with Pancreatic Cancer, run by Mayo Clinic at 1 site in United States.
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 2 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 6 Jan 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total DNA Yield of Adenocarcinoma (time frame: Baseline). 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 6 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.