Randomized Trial for Optimal Number of Passes Required for Molecular Profiling During EUS-FNB of Pancreatic Cancer

January 11, 2023 updated by: Orlando Health, Inc.

Randomized Trial to Evaluate the Optimal Number of Passes Required for Molecular Profiling During Endoscopic Ultrasound-guided Fine Needle Biopsy of Pancreatic Adenocarcinoma

This is a randomized trial to evaluate the optimal number of passes required during endoscopic ultrasound-guided fine needle biopsy for molecular profiling in pancreatic cancer

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Endoscopic ultrasound-guided fine needle tissue acquisition is currently the gold standard for sampling solid pancreatic masses. By using novel fine needle biopsy (FNB) needles during EUS-guided tissue sampling, core tissue samples can also now be obtained, with diagnostic adequacy of >90%.

Molecular profiling is becoming increasingly important in the management of pancreatic adenocarcinoma for targeted therapy. As the procurement of core tissue is possible with EUS-FNB, adequate tissue can now be obtained for molecular profiling. However, the number of passes required during EUS-FNB to obtain sufficient quantity of core tissue to successfully perform molecular profiling is unknown, although usually 2-3 passes are performed as standard of care practice.

The primary aim of this study is therefore to elucidate the optimal number of passes required during EUS-FNB to procure adequate tissue for molecular profiling in patients with pancreatic adenocarcinoma.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years and over
  2. Suspected or confirmed pancreatic mass seen on imaging, requiring endoscopic ultrasound-guided fine needle biopsy

Exclusion Criteria:

  1. Age < 18 years
  2. Females who are pregnant
  3. Pancreatic mass is not accessible for fine needle biopsy via endoscopic ultrasound
  4. Biopsied pancreatic mass is not adenocarcinoma on pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Two passes performed during EUS-FNB of pancreatic adenocarcinoma
Once the pancreatic mass is identified on endoscopic ultrasound examination, total of two passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.
Procedure: 2 passes during EUS-guided fine needle biopsy
Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of two passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
Active Comparator: Three passes performed during EUS-FNB of pancreatic adenocarcinoma
Once the pancreatic mass is identified on endoscopic ultrasound examination, total of three passes will be performed during find needle biopsy and placed in 10% formalin for processing for molecular profiling.
Procedure: 3 passes during EUS-guided fine needle biopsy
Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of three passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy
Time Frame: 7 days
Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy of pancreatic adenocarcinoma, with comparison between two and three passes during fine needle biopsy
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of actionable mutations detected on molecular profiling
Time Frame: 7 days
Number of actionable mutations detected on molecular profiling
7 days
Rate of technical success
Time Frame: 1 day
Rate of technical success of EUS-guided fine needle biopsy. Technical success is defined as the successful completion of the EUS-guided fine needle biopsy procedure.
1 day
Rate of procedure-related adverse events
Time Frame: 7 days
Rate of procedure-related adverse events, defined as any adverse event occurring as a result of EUS-guided fine needle biopsy
7 days
Type of actionable mutations detected on molecular profiling
Time Frame: 7 days
Type of actionable mutations detected on molecular profiling
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orlando Health, Inc.

Investigators

  • Principal Investigator: Ji Young Bang, MD MPH, Orlando Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21.069.05
  • 1741103 (Other Identifier: Orlando Health IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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