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Tissue Sampling
EUS-Guided Biopsy vs Aspiration for Pancreatic Cancer
Phase 4
Waitlist Available
Led By Vanessa Shami, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than 18 and less than 90 years
Presence of a solid (greater than 60%) mass lesion within the pancreas on cross-sectional imaging, without a preceding tissue diagnosis
Must not have
Age less than 18 or greater than 90 years
The patient has an uncorrectable coagulopathy as defined by a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) which does not improve with administration of fresh frozen plasma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing if a less invasive method of testing for pancreatic tumors is just as effective as the current standard method.
Who is the study for?
This trial is for English-speaking adults aged 18-90 with a solid pancreatic mass lesion, who have not yet had a tissue diagnosis. They must be scheduled for diagnostic endosonography and cannot have uncorrectable blood clotting issues. Pregnant individuals or those unable to understand the consent form are excluded.
What is being tested?
The study compares two methods of obtaining tissue samples from the pancreas: Fine Needle Aspiration (FNA) and Core biopsy (FNB). It aims to determine which method has better diagnostic yield, ease of use, and technical success in evaluating pancreatic tumors.
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, minor bleeding, bruising or infection. Rarely more serious complications like significant bleeding or injury to surrounding organs could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 90 years old.
Select...
I have a solid mass in my pancreas seen on scans, without a biopsy done yet.
Select...
My blood clotting tests are normal or can be corrected.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am younger than 18 or older than 90.
Select...
My blood does not clot properly even after treatment.
Select...
My pancreatic tumor is mostly made up of cysts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fine Needle Aspiration and Core BiospsyExperimental Treatment1 Intervention
Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fine Needle Aspiration (FNA) and Core biopsy (FNB)
2011
Completed Phase 4
~40
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
785 Previous Clinical Trials
1,316,406 Total Patients Enrolled
Vanessa Shami, MDPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for an endosonography.I am younger than 18 or older than 90.My blood does not clot properly even after treatment.My pancreatic tumor is mostly made up of cysts.There are no masses found during an endosonography.I am between 18 and 90 years old.I have a solid mass in my pancreas seen on scans, without a biopsy done yet.My blood clotting tests are normal or can be corrected.
Research Study Groups:
This trial has the following groups:- Group 1: Fine Needle Aspiration and Core Biospsy
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.