Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoidosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FNA | Procedure | — | UNRESOLVED |
| FNB | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FNA group
- description
- Group of patients randomized to endoscopic ultrasound (EUS-B) using the standard FNA needle
- interventionNames
- Procedure: FNA
- type
- EXPERIMENTAL
- label
- FNB group
- description
- Group of patients randomized to endoscopic ultrasound (EUS-B) using the FNB needle
- interventionNames
- Procedure: FNB
Primary outcomes (1)
- measure
- Conclusive diagnosis for optimal individualized treatment
- timeFrame
- When the pathology report is ready (typically 1 week after intervention) and up to 4 weeks after
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (13)
- BACKGROUNDYang Y, Aruna, Cheng B, Xiong D, Kuang D, Cui H, Xiong S, Mao X, Feng Y, Zhao Y. Comparison of Fine-Needle Biopsy (FNB) versus Fine-Needle Aspiration (FNA) Combined with Flow Cytometry in the Diagnosis of Deep-Seated Lymphoma. Diagnostics (Basel). 2023 Aug 28;13(17):2777. doi: 10.3390/diagnostics13172777. PMID 37685315
- BACKGROUNDLayfield LJ. The Papanicolaou Society of Cytopathology classification for pulmonary specimens: an overview. Cytopathology. 2016 Jun;27(3):149-52. doi: 10.1111/cyt.12344. PMID 27221749
- BACKGROUNDSkovgaard Christiansen I, Kuijvenhoven JC, Bodtger U, Naur TMH, Ahmad K, Singh Sidhu J, Nessar R, Salih GN, Hoegholm A, Annema JT, Clementsen PF. Endoscopic Ultrasound with Bronchoscope-Guided Fine Needle Aspiration for the Diagnosis of Paraesophageally Located Lung Lesions. Respiration. 2019;97(4):277-283. doi: 10.1159/000492578. Epub 2018 Sep 25. PMID 30253411
- BACKGROUNDvon Bartheld MB, van Breda A, Annema JT. Complication rate of endosonography (endobronchial and endoscopic ultrasound): a systematic review. Respiration. 2014;87(4):343-51. doi: 10.1159/000357066. Epub 2014 Jan 16. PMID 24434575
- BACKGROUNDSkinner TR, Churton J, Edwards TP, Bashirzadeh F, Zappala C, Hundloe JT, Tan H, Pattison AJ, Todman M, Hartel GF, Fielding DI. A randomised study of comfort during bronchoscopy comparing conscious sedation and anaesthetist-controlled general anaesthesia, including the utility of bispectral index monitoring. ERJ Open Res. 2021 May 31;7(2):00895-2020. doi: 10.1183/23120541.00895-2020. eCollection 2021 Apr. PMID 34084784
- BACKGROUNDDe S. Assessment of patient satisfaction and lidocaine requirement during flexible bronchoscopy without sedation. J Bronchology Interv Pulmonol. 2009 Jul;16(3):176-9. doi: 10.1097/LBR.0b013e3181afca25. PMID 23168547
- Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6):1432-1438. doi: 10.1016/j.gie.2017.11.036. Epub 2018 Jan 3.