Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes

NCT03975855 | Completed

• 1 other identifier: NEODOC-2021668610-165
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 7

Brief Summary

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

Breast Cancer

Keywords

Breast Cancer; Axillary Lymph Nodes; Biopsy

Outcome Measures

Primary Outcomes (1)

• Rate of successful biopsies (= success rates)

  Lymph node tissue present in biopsy samples as assessed by histopathologist

  after histopathological analysis af tissue samples, up to 1 week after biopsy

Secondary Outcomes (5)

• Rate of patients presenting with risk parameters for an anatomically complex procedure

  time of biopsy, 1 day

• Rate of cases in which it was possible to target the selected lymph node or, if present, the lesion inside the node

  time of biopsy, 1 day

• Rate of cases in which pulses facilitated control during needle insertion

  time of biopsy, 1 day

• Sensitivity

  post-surgery, up to 200 days

• Specificity

  post-surgery, up to 200 days

Study Arms (1)

Suspicious axillary lymph nodes

All patients with histologically confirmed breast cancer or highly suspicious breast lesions presenting with suspicious axillary lymph nodes

Device: NeoNavia® Biopsy System

Interventions

NeoNavia® Biopsy System DEVICE

Biopsy of axillary lymph node using the NeoNavia Biopsy System. The investigator shall obtain as many/large samples as judged adequate and sufficient for diagnosis.

Suspicious axillary lymph nodes

Eligibility Criteria

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

Study Population

Patients recruited from eight university hospitals in Germany

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NeoDynamics AB: lead

Study Sites (7)

Klinikum Esslingen

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

Universitätsfrauenklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt am Main, Hesse, 60431, Germany

Location

Universitäts-Frauenklinik

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50226, Germany

Location

HJK Erkelenz

Erkelenz, North Rhine-Westphalia, 41812, Germany

Location

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45136, Germany

Location

Related Publications (8)

• Schassburger 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 BACKGROUND

• Gruber 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 BACKGROUND

• Nakamura 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 BACKGROUND

• Garcia-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 BACKGROUND

• Abe 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 BACKGROUND

• Kim 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 BACKGROUND

• 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.

  PMID: 24649373 BACKGROUND

• Damera A, Evans AJ, Cornford EJ, Wilson AR, Burrell HC, James JJ, Pinder SE, Ellis IO, Lee AH, Macmillan RD. Diagnosis of axillary nodal metastases by ultrasound-guided core biopsy in primary operable breast cancer. Br J Cancer. 2003 Oct 6;89(7):1310-3. doi: 10.1038/sj.bjc.6601290.

  PMID: 14520465 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marc Thill, PD Dr.

  Leading Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 5, 2019
• Study Start: February 14, 2019
• Primary Completion: June 30, 2021
• Study Completion: April 11, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

DE (7)