Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes (NCT03975855) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes
Germany140 participantsStarted 2019-02-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of successful biopsies (= success rates)
Timeframe: after histopathological analysis af tissue samples, up to 1 week after biopsy