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

NCT06848738 | Enrolling By Invitation

• 1 other identifier: REG-027-2024
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 3

Brief 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

Lung Cancer; Lymphoma; Sarcoidosis

Keywords

endoscopic ultrasound; lung cancer; lymphoma; EUS-B

Outcome Measures

Primary Outcomes (1)

• Conclusive diagnosis for optimal individualized treatment

  The proportion of patients with lung cancer or Lymphoma / sarcoidosis with a comprehensive diagnostic result. Definition: In the suspected lung cancer group: Comprehensive diagnostic results = genomic analysis defined as a successful NGS (next generation sequencing) assay. In the suspected lymphoma group: Comprehensive diagnostic results = Either a lymphoma diagnosis with successful subtyping based on flowcytometry, immunohistochemistry and NGS (when in doubt) or sarcoidosis with the finding of nonnecrotizing granulomatous inflammation.

  When the pathology report is ready (typically 1 week after intervention) and up to 4 weeks after

Secondary Outcomes (7)

• NGS sequencing quality

  When the pathology report is ready (typically 1 week after intervention) and up to 4 weeks after

• Diagnostic yield

  When the pathology report is ready (typically 1 week after intervention) and up to 6 months after endoscopy

• Adverse events

  From endoscopy until one week after

• Patient reported symptoms

  Right before endoscopy, 1 hour after, 1 day after and 1 week after endoscopy

• Willingness to repeat the procedure

  1 hour after endoscopy

Study Arms (2)

FNA group

ACTIVE COMPARATOR

Group of patients randomized to endoscopic ultrasound (EUS-B) using the standard FNA needle

Procedure: FNA

FNB group

EXPERIMENTAL

Group of patients randomized to endoscopic ultrasound (EUS-B) using the FNB needle

Procedure: FNB

Interventions

FNB PROCEDURE

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

Also known as: Fine needle biopsy

FNB group

FNA PROCEDURE

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

Also known as: Fine needle aspiration

FNA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead
• Odense University Hospital: collaborator

Study Sites (3)

Department of Medicine, Zealand University Hospital, Næstved

Næstved, 4700, Denmark

Location

Department of Respiratory Medicine, Odense University Hospital

Odense, 5000, Denmark

Location

Department of Medicine, Zealand University Hospital, Roskilde

Roskilde, 4000, Denmark

Location

Related Publications (13)

• Yang 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 BACKGROUND

• Layfield 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 BACKGROUND

• Skovgaard 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 BACKGROUND

• von 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 BACKGROUND

• Skinner 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 BACKGROUND

• De 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 BACKGROUND

• 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.

  PMID: 29305893 BACKGROUND

• Karsenti D, Palazzo L, Perrot B, Zago J, Lemaistre AI, Cros J, Napoleon B. 22G Acquire vs. 20G Procore needle for endoscopic ultrasound-guided biopsy of pancreatic masses: a randomized study comparing histologic sample quantity and diagnostic accuracy. Endoscopy. 2020 Sep;52(9):747-753. doi: 10.1055/a-1160-5485. Epub 2020 May 14.

  PMID: 32408361 BACKGROUND

• Oezkan F, Byun WY, Loeffler C, Siebolts U, Diessel L, Lambrecht N, Eisenmann S. Crown-Cut Endobronchial Ultrasound Guided Transbronchial Aspiration Needle: First Real-World Experiences. J Clin Med. 2021 Dec 29;11(1):163. doi: 10.3390/jcm11010163.

  PMID: 35011904 BACKGROUND

• Izumo T, Sasada S, Watanabe J, Chavez C, Matsumoto Y, Tsuchida T. Comparison of two 22 G aspiration needles for histologic sampling during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Jpn J Clin Oncol. 2014 Sep;44(9):841-5. doi: 10.1093/jjco/hyu095. Epub 2014 Jul 23.

  PMID: 25057090 BACKGROUND

• Manley CJ, Kumar R, Gong Y, Huang M, Wei SS, Nagarathinam R, Haber A, Egleston B, Flieder D, Ehya H. Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology. J Am Soc Cytopathol. 2022 Mar-Apr;11(2):114-121. doi: 10.1016/j.jasc.2021.10.003. Epub 2021 Oct 23.

  PMID: 34896033 BACKGROUND

• Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4.

  PMID: 30914312 BACKGROUND

• Faber E, Grosu H, Sabir S, San Lucas FA, Barkoh BA, Bassett RL, Luthra R, Stewart J, Roy-Chowdhuri S. Adequacy of small biopsy and cytology specimens for comprehensive genomic profiling of patients with non-small-cell lung cancer to determine eligibility for immune checkpoint inhibitor and targeted therapy. J Clin Pathol. 2022 Sep;75(9):612-619. doi: 10.1136/jclinpath-2021-207597. Epub 2021 May 5.

  PMID: 33952592 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Lymphoma; Sarcoidosis

Interventions

Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hypersensitivity, Delayed; Hypersensitivity

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Uffe Bodtger, MD, PhD

  Department of Medicine, Zealand University Hospital, Roskilde, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the department of Pathology (including NGS technicians) are blinded to needle type (FNA vs FNB needle).
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: February 27, 2025
• Study Start: May 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)