NCT03485924 is a NA clinical trial of EUS-FNA with ROSE in Fine Needle Aspiration, sponsored by Johns Hopkins University.

Who is sponsoring NCT03485924?

NCT03485924 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT03485924?

Interventions in NCT03485924: EUS-FNA with ROSE, EUS-FNB without ROSE.

What condition does NCT03485924 study?

NCT03485924 studies Fine Needle Aspiration, Pancreatic Mass.

Is NCT03485924 still recruiting?

NCT03485924 is currently terminated. Last updated 19 September 2024.

Are results published for NCT03485924?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-19 · How we verify

NCT03485924

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses

Terminated NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing EUS-FNA with ROSE in Fine Needle Aspiration in 40 participants. Terminated before completion.

Timeline

12 April 2018

Primary endpoint
26 July 2023

26 July 2023

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	40
Start date	12 April 2018
Primary completion	26 July 2023
Estimated completion	26 July 2023
Sites	1 location across United States

Drugs / interventions tested

EUS-FNA with ROSE
EUS-FNB without ROSE

Conditions studied

Fine Needle Aspiration — all drugs for Fine Needle Aspiration →
Pancreatic Mass — all drugs for Pancreatic Mass →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Fine Needle Aspiration or Pancreatic Mass. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Diagnostic Accuracy of Fine-needle Biopsy (FNB) Sampling Without Rapid Onsite Evaluation (ROSE) and the Fine Needle Aspiration (FNA) With ROSE in Pancreatic Mass Lesions Primary · 6 months from the initial biopsy

Diagnostic accuracy will be defined as (true positive + true negative)/all participants in the arm.

Group	Value	95% CI
EUS-FNA With ROSE	91.3
EUS-FNB Without ROSE	94.1

Specimen Adequacy Secondary · Post-procedure one week

Number of Specimens with Final Histopathological Diagnosis

Group	Value	95% CI
EUS-FNA With ROSE	35
EUS-FNB Without ROSE	47

Number of Histology Cores Obtained Secondary · Post-procedure one week

Number of Samples with Visible Histology Core Biopsy

Group	Value	95% CI
EUS-FNA With ROSE	3
EUS-FNB Without ROSE	46

Median Number of Passes Secondary · 6 months from the initial biopsy

Median number of passes required for accurate diagnosis

Group	Value	95% CI
EUS-FNA With ROSE	2	1 – 3
EUS-FNB Without ROSE	1	1 – 1

Number of Technical Failures Secondary · After the procedure, an average of 1 hour

Technical failure was defined as the inability to perform the procedure, including the need to change the needle

Group	Value	95% CI
EUS-FNA With ROSE	0
EUS-FNB Without ROSE	0

Sponsor's own description

The objective of this paired cohort study is to evaluate the diagnostic accuracy of Endoscopic Ultrasound-fine needle aspiration (EUS-FNA) with rapid onsite evaluation (ROSE) compared to EUS-fine needle biopsy (EUS-FNB) without ROSE. If EUS-FNB without ROSE is shown to be non-inferior to the current standard of care of EUS-FNA with ROSE in pancreatic lesions, this study has the potential to make EUS-guided tissue acquisition more economical (with elimination for the need for cytopathology staff onsite) as well as provide core histological specimen without sacrificing the overall diagnostic yield.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03485924 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 19 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03485924.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing