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

Sponsor

Orlando Health, Inc. (Other)

Overall Status

Recruiting

CT.gov ID

NCT05043532

Collaborator

(none)

Enrollment

Location

Arms

22.4

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Pancreatic Neoplasms Adenocarcinoma of the Pancreas	Procedure: 2 passes during EUS-guided fine needle biopsy Procedure: 3 passes during EUS-guided fine needle biopsy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

The patient undergoing the procedure, research coordinator calling patients for follow-up and the pathologist performing molecular profiling will be blinded to the randomization group.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 18, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of ability to perform successful molecular profiling in core tissue obtained during EUS-guided fine needle biopsy [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

Secondary Outcome Measures

Number of actionable mutations detected on molecular profiling [7 days]
Number of actionable mutations detected on molecular profiling
Rate of technical success [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.
Rate of procedure-related adverse events [7 days]
Rate of procedure-related adverse events, defined as any adverse event occurring as a result of EUS-guided fine needle biopsy
Type of actionable mutations detected on molecular profiling [7 days]
Type of actionable mutations detected on molecular profiling

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orlando Health	Orlando	Florida	United States	32806

Sponsors and Collaborators

Orlando Health, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Orlando Health, Inc.

ClinicalTrials.gov Identifier:

NCT05043532

Other Study ID Numbers:

21.069.05

First Posted:

Sep 14, 2021

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Pancreatic Neoplasms

Study Results

No Results Posted as of Sep 14, 2021