Clinical trial · Observational
Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes
Percutaneous Ultrasound-Guided Biopsy Evaluated for Axillary Lymph Node Sampling Efficacy (PULSE)
- 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)
The aim of the study is to document performance characteristics of a biopsy device indicated for use in axillary lymph nodes, to provide basic insights into the complexity of axillary biopsy procedures and generate hypothesis for further larger comparative trials. This is a Sponsor-initiated prospective, multicenter, registry trial. Patients that present with suspicious axillary lymph nodes at the time of breast cancer diagnosis undergo axillary sampling using the NeoNavia biopsy system. This is in accordance with clinical routine and current clinical guidelines. The system incorporates a new mechanism for controllable and precise needle insertion and a newly developed sampling needle for high yield sampling acquisition. It is approved for use in the breast and axillary lymph nodes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NeoNavia® Biopsy System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Suspicious axillary lymph nodes
- description
- All patients with histologically confirmed breast cancer or highly suspicious breast lesions presenting with suspicious axillary lymph nodes
- interventionNames
- Device: NeoNavia® Biopsy System
Primary outcomes (1)
- measure
- Rate of successful biopsies (= success rates)
- timeFrame
- after histopathological analysis af tissue samples, up to 1 week after biopsy
- description
- Lymph node tissue present in biopsy samples as assessed by histopathologist
Secondary outcomes (5)
- measure
- Rate of patients presenting with risk parameters for an anatomically complex procedure
- timeFrame
- time of biopsy, 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * cT1-4c (multifocality / multicentricity permitted) * Female / male patient aged ≥ 18 years * cN+ based on the following criteria (at least one criteria must be met): * lymph node is palpable * cortical asymmetry (focal or diffuse cortical thickening of \>3mm) under US * cortex:hilum ratio \>2:1 under US * loss of hilum/cortex structure under US * Written informed consent (ICF) Exclusion Criteria: * Suspicious lymph nodes after neoadjuvant therapy * No confirmed breast cancer and no abnormality in the breast * Patient uses Marcumar * Pregnant and lactating women * Known hypersensitivity reaction against local anesthesia * Prior chemo or radiation therapy in breast or axilla * Missing written informed consent
References
Publications (8)
- BACKGROUNDSchassburger KU, Paepke S, Saracco A, Azavedo E, Ekstrom C, Wiksell H. High velocity pulse biopsy device enables controllable and precise needle insertion and high yield tissue acquisition. Phys Med. 2018 Feb;46:25-31. doi: 10.1016/j.ejmp.2017.12.014. Epub 2018 Jan 30. PMID 29519406
- BACKGROUNDGruber I, Hahn M, Fehm T, Hann von Weyhern C, Stabler A, Winckelmann A, Wallwiener D, Kuhn T. Relevance and methods of interventional breast sonography in preoperative axillary lymph node staging. Ultraschall Med. 2012 Aug;33(4):337-43. doi: 10.1055/s-0031-1273317. Epub 2011 May 26. PMID 21618166
- BACKGROUNDNakamura R, Yamamoto N, Miyaki T, Itami M, Shina N, Ohtsuka M. Impact of sentinel lymph node biopsy by ultrasound-guided core needle biopsy for patients with suspicious node positive breast cancer. Breast Cancer. 2018 Jan;25(1):86-93. doi: 10.1007/s12282-017-0795-7. Epub 2017 Jul 22. PMID 28735457
- BACKGROUNDGarcia-Ortega MJ, Benito MA, Vahamonde EF, Torres PR, Velasco AB, Paredes MM. Pretreatment axillary ultrasonography and core biopsy in patients with suspected breast cancer: diagnostic accuracy and impact on management. Eur J Radiol. 2011 Jul;79(1):64-72. doi: 10.1016/j.ejrad.2009.12.011. Epub 2010 Jan 4. PMID 20047809
- BACKGROUNDAbe H, Schmidt RA, Kulkarni K, Sennett CA, Mueller JS, Newstead GM. Axillary lymph nodes suspicious for breast cancer metastasis: sampling with US-guided 14-gauge core-needle biopsy--clinical experience in 100 patients. Radiology. 2009 Jan;250(1):41-9. doi: 10.1148/radiol.2493071483. Epub 2008 Oct 27. PMID 18955508
- BACKGROUNDKim KH, Son EJ, Kim EK, Ko KH, Kang H, Oh KK. The safety and efficiency of the ultrasound-guided large needle core biopsy of axilla lymph nodes. Yonsei Med J. 2008 Apr 30;49(2):249-54. doi: 10.3349/ymj.2008.49.2.249. PMID 18452262
- Ganott MA, Zuley ML, Abrams GS, Lu AH, Kelly AE, Sumkin JH, Chivukula M, Carter G, Austin RM, Bandos AI. Ultrasound Guided Core Biopsy versus Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients with Breast Cancer. ISRN Oncol. 2014 Feb 4;2014:703160. doi: 10.1155/2014/703160. eCollection 2014.