Breast NeoplasmsNCT03130946
Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes
A study testing Cryo-assisted core needle biopsy and FNA in people with Breast Neoplasms, run by Peking University People's Hospital at 1 site in China.
Trial summary
Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Cryo-assisted core needle biopsy and FNA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Dec 2023
- Phase
- Interventional
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed invasive breast cancer.
- With axillary lymph node with thickened cortex.
- Planned for sentinel lymph node biopsy or axillary clearance.
Who cannot join
- Nodes ultrasonographically normal.
- Nodes with hilar displacement .
- Palpable matted nodes.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 10044
About this study
Official title: Comparison of the Accuracy and Safety of Biopsy in Suspicious Axillary Lymph Nodes With a Crypo-assisted Stick Freeze Biopsy Device or Fine Needle Aspiration
Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. This prospective study is to compare the performance of a crpo-assisted core biopsy with FNA.
Read the detailed description
This prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (Cassi II, USA) compared with FNA for biopsy of intermediately suspicious lymph nodes. Eligible patients would be randomized to one of two arms by 1:2 : Core with FNA or FNA alone. The diagnostic accuracy and adverse outcome of core and FNA would be compared.
- Conditions
- Breast Neoplasms
- Being tested
- Cryo-assisted core needle biopsy, FNA
- Keywords
- breast neoplasms, Ultrasonography, Interventional, Biopsy, Large-Core Needle, Biopsy, Fine-Needle
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo-assisted core needle biopsyDevice
Rotational core needle biopsy would be done under local anesthesia. A small incision would be made in the axilla and core needle biopsy be performed using a special cryo-assisted stick freeze device (Cassi II, Scion Medical Technologies, USA). The cytological and histological specimens would be sent for diagnosis.
FNADevice
FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Cryo-assisted core needle biopsy | Experimental | Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially. Receives: Device: Cryo-assisted core needle biopsy; Device: FNA |
| Fine needle aspiration alone | Active comparator | Patients undergo lymph node biopsy with FNA alone. Receives: Device: FNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of biopsy
True positive rate measures the proportion of positives that are correctly identified by Core needle or FNA
Measured: Immediate after pathological lymph node stage is available
Secondary outcomes (3)
Specificity
The true negative rate measures the proportion of negatives that are correctly identified.
Measured: Immediate after pathological lymph node stage is available.
Sample adequency
The specimen amount or quality for diagnosis is adequate or not evaluated by pathologists
Measured: Immediate after biopsy specimen is evaluated by pathologists.
Adverse effect of surgery
Hematoma, bleeding need , suture exposure and extrusion.
Measured: 4 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 May 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Slow recruiting rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, prospective, open label study
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Houpu Yang, Peking University People's Hospital
- Investigators
- Shu Wang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130946
- Sponsor's protocol ID
- Axbiopsy
- Status last verified
- Oct 2022
- First submitted
- 23 Apr 2017
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Accuracy and Safety of Biopsy in Suspicious Axillary Lymph Nodes With a Crypo-assisted Stick Freeze Biopsy Device or Fine Needle Aspiration
- ClinicalTrials.gov ID
- NCT03130946
- Acronym / sponsor ID
- Axbiopsy
- Conditions
- Breast Neoplasms
- Keywords
- breast neoplasms, Ultrasonography, Interventional, Biopsy, Large-Core Needle, Biopsy, Fine-Needle
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Slow recruiting rate.
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Apr 2017 (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.
Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. This prospective study is to compare the performance of a crpo-assisted core biopsy with FNA.
Detailed description
This prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (Cassi II, USA) compared with FNA for biopsy of intermediately suspicious lymph nodes. Eligible patients would be randomized to one of two arms by 1:2 : Core with FNA or FNA alone. The diagnostic accuracy and adverse outcome of core and FNA would be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm, prospective, open label study
| Arm | Type | Receives |
|---|---|---|
| Cryo-assisted core needle biopsy | Experimental | Device: Cryo-assisted core needle biopsy, Device: FNAEligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially. |
| Fine needle aspiration alone | Active comparator | Device: FNAPatients undergo lymph node biopsy with FNA alone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed invasive breast cancer.
- With axillary lymph node with thickened cortex.
- Planned for sentinel lymph node biopsy or axillary clearance.
Key exclusion criteria (3 listed)
- Nodes ultrasonographically normal.
- Nodes with hilar displacement .
- Palpable matted nodes.
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 |
|---|---|---|
| Cryo-assisted core needle biopsyRotational core needle biopsy would be done under local anesthesia. A small incision would be made in the axilla and core needle biopsy be performed using a special cryo-assisted stick freeze device (Cassi II, Scion Medical Technologies, USA). The cytological and histological specimens would be sent for diagnosis. | Device | Cryo-assisted core needle biopsy |
| FNAFNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia. | Device | Cryo-assisted core needle biopsy, Fine needle aspiration alone |
Primary outcome
Sensitivity of biopsy
Time frame: Immediate after pathological lymph node stage is available
True positive rate measures the proportion of positives that are correctly identified by Core needle or FNA
3 secondary outcomes
Specificity
Time frame: Immediate after pathological lymph node stage is available.
Sample adequency
Time frame: Immediate after biopsy specimen is evaluated by pathologists.
Adverse effect of surgery
Time frame: 4 weeks after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Shu Wang, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryo-assisted core needle biopsy and FNA in people with Breast Neoplasms, run by Peking University People's Hospital at 1 site in China.
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 3 inclusion and 3 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: paused, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
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?
Sensitivity of biopsy (time frame: Immediate after pathological lymph node stage is available). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2022.