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NCT06848738Enrolling by invitation

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

Improving Genomic Profiling and Reducing Time to Non-small Cell Lung Cancer or Lymphoma Treatment Via Targeted Use of Endoscopic Ultrasound: a Randomized Clinical Trial on the Diagnostic Accuracy of Tissue Sampling With FNA Versus FNB

Source: ClinicalTrials.gov · Last updated 27 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
362 (estimated)
First submitted
1 Aug 2024
Start date
7 May 2024
Primary completion date
1 Jun 2026
Lead sponsor
Zealand University Hospital
Diseases
Lung cancer
NCT number
NCT06848738

What you commit to

  • Study type: Interventional
  • Planned participants: 362
  • From 7 May 2024 to the primary completion date, 1 Jun 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Other previous cancer with CT or PET-CT suggesting recurrence (e.g. pulmonary metastasis)

Other

  • Uncorrected coagulopathies or anticoagulation treatment that cannot be discontinued
  • Pregnant or lactating women
  • CT suggesting interposed large vessels between the esophagus/stomach and target lesion

Who the study is looking for

  • Suspicion of lung cancer or lymphoma based on chest CT or PET-CT
  • Lesions adjacent to the esophagus/stomach (e.g. lung tumor, enlarged/FDG-avid lymph nodes in mediastinum or retroperitoneum, left liver lobe metastasis)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Medicine, Zealand University Hospital, Næstved
Coordinator of this site? Confirm its status
NæstvedDenmarkUnknown status
Department of Respiratory Medicine, Odense University Hospital
Coordinator of this site? Confirm its status
OdenseDenmarkUnknown status
Department of Medicine, Zealand University Hospital, Roskilde
Coordinator of this site? Confirm its status
RoskildeDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.