Comparing two biopsy needles to diagnose lung cancer and lymphoma
Tests two biopsy needles on lymph nodes in adults with suspected lung cancer or lymphoma.
Plain-language title generated from the registry record
Registry title: Improving Genomic Profiling and Reducing Time to Cancer Treatment Via Targeted Use of Endoscopic Ultrasound
Key facts
- Where
- Næstved, Odense, and Roskilde, DenmarkSee the 3 sites
Where in Denmark
- Department of Medicine, Zealand University Hospital, NæstvedNæstved, DenmarkNo longer taking part
- Department of Respiratory Medicine, Odense University HospitalOdense, DenmarkNo longer taking part
- Department of Medicine, Zealand University Hospital, RoskildeRoskilde, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zealand University Hospital
- Trial code
- NCT06848738
- Record updated
- 27 February 2025
- Original description
Aim:Read full original descriptionShow less
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
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.
Inclusion: 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).
Exclusion: Other previous cancer with CT or PET-CT suggesting recurrence (e.g. pulmonary metastasis); 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.