Breast CancerPULSENCT03975855
Evaluation of NeoNavia® Biopsy System in Axillary Lymph Nodes
An observational study of Breast Cancer, run by NeoDynamics AB at 7 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- NeoNavia® Biopsy System
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 7 sitesGermany
- Study dates
- 14 Feb 2019to 11 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited from eight university hospitals in Germany
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50226
HJK Erkelenz
Erkelenz, North Rhine-Westphalia, 41812
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45136
Klinikum Esslingen
Esslingen am Neckar, Baden-Wurttemberg, 73730
Agaplesion Markus Krankenhaus
Frankfurt am Main, Hesse, 60431
Universitäts-Frauenklinik
Rostock, Mecklenburg-Vorpommern, 18059
Universitätsfrauenklinik Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Percutaneous Ultrasound-Guided Biopsy Evaluated for Axillary Lymph Node Sampling Efficacy (PULSE)
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.
Read the detailed description
Determining axillary nodal status at the time of diagnosis is paramount for optimal staging and treatment planning. SLNB is indicated for patients with a clinical and radiological negative axilla. 25%-43% of breast cancer patients are reported to present with radiologically suspicious axillary lymph nodes at the time of diagnosis. In these patients, a pre-operative ultrasound-guided needle sampling of suspicious axillary lymph tissue is indicated.
This can rationalize patient care by identifying those with axillary metastases using merely a minimally-invasive intervention. These patients can be counselled with regards to proceeding directly to definitive axillary surgery in the form of axillary lymph node dissection (ALND) rather than sentinel node biopsy (SLNB), thereby omitting a potentially unnecessary surgical procedure. Patients with a negative axillary status can proceed to SLNB for definitive nodal status determination. Furthermore, in the paradigm of neoadjuvant treatment, confirming a histopathologic involvement of lymph nodes by US-guided needle biopsies enables for decision on neoadjuvant chemotherapy without the need for a surgical procedure.
The main challenge in performing CNB (Core Needle Biopsy) within the axilla is to avoid damaging the major vessels and nerves. Technical, operator and procedural requirements that mitigate risks in CNB sampling of the axilla have been reported in the literature. It is suggested that the operator shall fully acknowledge the detailed anatomy including vessels and nerves in the axilla, have good hand-eye coordination as well as be experienced in US-guided interventions. Proper positioning of the patient is reported to be important. Color Doppler ultrasound shall be used to assess the location of large vessels relative to the intended biopsy track and to avoid sampling a vascular component of the node. Perfect guiding and visualization of the needle tip at all times is reported to be essential. It is suggested that a biopsy device with a controllable needle action is safer to use. Omitting the firing action gives the operator greater control over the final needle tip placement.
Due to the difficulty of the procedure there may be inclusion bias in the reported studies. In one series, patients presenting with nodes adjacent to a vessel or located very deep and difficult to access were not asked to participate in the study and hence not subjected to CNB. In another study FNA (Fine Needle Aspiration) was performed instead of CNB when the lymph nodes were in close proximity to vessels. A recent German survey showed that merely 79% of breast centers (41/52) perform biopsies in the axilla (data on file), and anecdotal evidence suggests that in certain departments only the most experienced physician performs CNB procedures in axillary lymph nodes, risking economic/operational inefficiencies.
For the purpose of documenting the prevalence and composition of cases deemed challenging in this study, an experienced expert panel has compiled a comprehensive list of risk parameters characterizing the anatomic complexity and procedural difficulty of axillary lymph node needle biopsies.
Recently a new biopsy device indicated for the use in breast and axillary lymph nodes (NeoNavia biopsy system, NeoDynamics, Sweden) has become available. It incorporates a pneumatic needle insertion mechanism that is intended to provide better control of needle progression and enable stepwise insertion without noticeable deformation or displacement of surrounding tissue as visualized under ultrasound. Furthermore a new method of tissue acquisition is employed that has pre-clinically shown a higher sampling yield compared to CNB. These characteristics indicate that the device could be well suited for tackling even the most challenging cases of axillary lymph node biopsies. Initial clinical results indicate that in axillary lesions deemed "technically difficult", i.e. where prior US-guided biopsies with CNB or FNA had yielded non-diagnostic histology results, the NeoNavia device performed successfully thereby significantly altering clinical management.
- Conditions
- Breast Cancer
- Being tested
- NeoNavia® Biopsy System
- Keywords
- Breast Cancer, Axillary Lymph Nodes, Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoNavia® Biopsy SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Suspicious axillary lymph nodes | All patients with histologically confirmed breast cancer or highly suspicious breast lesions presenting with suspicious axillary lymph nodes Receives: Device: NeoNavia® Biopsy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful biopsies (= success rates)
Lymph node tissue present in biopsy samples as assessed by histopathologist
Measured: 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
Based on a list of parameters established by an expert panel to characterize the anatomic complexity of axillary biopsy procedures
Measured: 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
Measured: time of biopsy, 1 day
Rate of cases in which pulses facilitated control during needle insertion
Measured: time of biopsy, 1 day
Sensitivity
Measured: post-surgery, up to 200 days
Specificity
Measured: post-surgery, up to 200 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start14 Feb 2019
- Primary completion30 Jun 2021
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeoDynamics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Thill, PD Dr., Principal investigator, Leading Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975855
- Sponsor's protocol ID
- NEODOC-2021668610-165
- Acronym
- PULSE
- Status last verified
- Jun 2023
- First submitted
- 29 May 2019
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29519406Gruber 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.
PubMed 21618166Nakamura 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.
PubMed 28735457Garcia-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.
PubMed 20047809Abe 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.
PubMed 18955508Kim 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.
PubMed 18452262Ganott 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.
PubMed 24649373Damera 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.
PubMed 14520465
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Ultrasound-Guided Biopsy Evaluated for Axillary Lymph Node Sampling Efficacy (PULSE)
- ClinicalTrials.gov ID
- NCT03975855
- Acronym / sponsor ID
- PULSE / NEODOC-2021668610-165
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Axillary Lymph Nodes, Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- NeoDynamics ABIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Determining axillary nodal status at the time of diagnosis is paramount for optimal staging and treatment planning. SLNB is indicated for patients with a clinical and radiological negative axilla. 25%-43% of breast cancer patients are reported to present with radiologically suspicious axillary lymph nodes at the time of diagnosis. In these patients, a pre-operative ultrasound-guided needle sampling of suspicious axillary lymph tissue is indicated.
This can rationalize patient care by identifying those with axillary metastases using merely a minimally-invasive intervention. These patients can be counselled with regards to proceeding directly to definitive axillary surgery in the form of axillary lymph node dissection (ALND) rather than sentinel node biopsy (SLNB), thereby omitting a potentially unnecessary surgical procedure. Patients with a negative axillary status can proceed to SLNB for definitive nodal status determination. Furthermore, in the paradigm of neoadjuvant treatment, confirming a histopathologic involvement of lymph nodes by US-guided needle biopsies enables for decision on neoadjuvant chemotherapy without the need for a surgical procedure.
The main challenge in performing CNB (Core Needle Biopsy) within the axilla is to avoid damaging the major vessels and nerves. Technical, operator and procedural requirements that mitigate risks in CNB sampling of the axilla have been reported in the literature. It is suggested that the operator shall fully acknowledge the detailed anatomy including vessels and nerves in the axilla, have good hand-eye coordination as well as be experienced in US-guided interventions. Proper positioning of the patient is reported to be important. Color Doppler ultrasound shall be used to assess the location of large vessels relative to the intended biopsy track and to avoid sampling a vascular component of the node. Perfect guiding and visualization of the needle tip at all times is reported to be essential. It is suggested that a biopsy device with a controllable needle action is safer to use. Omitting the firing action gives the operator greater control over the final needle tip placement.
Due to the difficulty of the procedure there may be inclusion bias in the reported studies. In one series, patients presenting with nodes adjacent to a vessel or located very deep and difficult to access were not asked to participate in the study and hence not subjected to CNB. In another study FNA (Fine Needle Aspiration) was performed instead of CNB when the lymph nodes were in close proximity to vessels. A recent German survey showed that merely 79% of breast centers (41/52) perform biopsies in the axilla (data on file), and anecdotal evidence suggests that in certain departments only the most experienced physician performs CNB procedures in axillary lymph nodes, risking economic/operational inefficiencies.
For the purpose of documenting the prevalence and composition of cases deemed challenging in this study, an experienced expert panel has compiled a comprehensive list of risk parameters characterizing the anatomic complexity and procedural difficulty of axillary lymph node needle biopsies.
Recently a new biopsy device indicated for the use in breast and axillary lymph nodes (NeoNavia biopsy system, NeoDynamics, Sweden) has become available. It incorporates a pneumatic needle insertion mechanism that is intended to provide better control of needle progression and enable stepwise insertion without noticeable deformation or displacement of surrounding tissue as visualized under ultrasound. Furthermore a new method of tissue acquisition is employed that has pre-clinically shown a higher sampling yield compared to CNB. These characteristics indicate that the device could be well suited for tackling even the most challenging cases of axillary lymph node biopsies. Initial clinical results indicate that in axillary lesions deemed "technically difficult", i.e. where prior US-guided biopsies with CNB or FNA had yielded non-diagnostic histology results, the NeoNavia device performed successfully thereby significantly altering clinical management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicious axillary lymph nodes | – | Device: NeoNavia® Biopsy SystemAll patients with histologically confirmed breast cancer or highly suspicious breast lesions presenting with suspicious axillary lymph nodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from eight university hospitals in Germany
Key inclusion criteria (8 listed)
- cT1-4c (multifocality / multicentricity permitted)
- Female / male patient aged ≥ 18 years
- cN+ based on the following criteria (at least one criteria must be met):
- Written informed consent (ICF)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoNavia® Biopsy SystemBiopsy of axillary lymph node using the NeoNavia Biopsy System. The investigator shall obtain as many/large samples as judged adequate and sufficient for diagnosis. | Device | Suspicious axillary lymph nodes |
Primary outcome
Rate of successful biopsies (= success rates)
Time frame: after histopathological analysis af tissue samples, up to 1 week after biopsy
Lymph node tissue present in biopsy samples as assessed by histopathologist
5 secondary outcomes
Rate of patients presenting with risk parameters for an anatomically complex procedure
Time frame: 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 frame: time of biopsy, 1 day
Rate of cases in which pulses facilitated control during needle insertion
Time frame: time of biopsy, 1 day
Sensitivity
Time frame: post-surgery, up to 200 days
Specificity
Time frame: post-surgery, up to 200 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Background: PubMed 29519406Schassburger 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.
- Background: PubMed 21618166Gruber 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.
- Background: PubMed 28735457Nakamura 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.
- Background: PubMed 20047809Garcia-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.
- Background: PubMed 18955508Abe 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.
- Background: PubMed 18452262Kim 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.
- Background: PubMed 24649373Ganott 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.
- Background: PubMed 14520465Damera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Thill, PD Dr. principal investigator
Leading Principal Investigator
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by NeoDynamics AB at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful biopsies (= success rates) (time frame: after histopathological analysis af tissue samples, up to 1 week after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975855, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.