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Improving Genomic Profiling and Reducing Time to Cancer Treatment Via Targeted Use of Endoscopic Ultrasound

NCT06848738 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2025-02-27

No results posted yet for this study

Summary

Aim:

To investigate whether the novel 3rd generation FNB needle provides a better diagnostic accuracy than a standard FNA needle in EUS-B guided diagnosis of common deep seated thoracic malignancies (lung cancer and lymphoma).

Short study description:

Consecutive patients referred due to suspected cancer with enlarged (at least 10 mm in the shortest axis) and/or FDG-avid lymph nodes or other lesions adjacent to the esophagus/stomach (e.g. suspected liver metastasis), thus with an indication for EUS-B, will be randomly assigned for tissue sampling either with a standard 22G FNA needle, or the novel 22G crown-cut FNB needle.

280 patients with suspected lung cancer will be included and inclusion will end when the targeted number of 254 patients (127 in each group) with a final diagnosis of lung cancer is reached.

Likewise, 82 patients with suspected lymphoma will be included until the targeted number of 74 patients (37 in each group) with a final diagnosis of lymphoma or sarcoidosis is reached.

Primary outcome: proportion of patients with a comprehensive diagnostic result in each needle arm for patients with lung cancer and lymphoma / sarcoidosis.

Conditions

Interventions

PROCEDURE

FNB

Endoscopic ultrasound for suspected lung cancer or lymphoma is performed to obtain tissue samples from suspected lesions with the 3rd generation FNB needle

PROCEDURE

FNA

Endoscopic ultrasound for suspected lung cancer or lymphoma is performed to obtain tissue samples from suspected lesions with the standard FNA needle

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Uffe Bodtger, MD, PhD · Department of Medicine, Zealand University Hospital, Roskilde, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06848738 on ClinicalTrials.gov