Breast NeoplasmsAsclepiusNCT04932460
Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy
A study testing CEUS and blue dye in people with Breast Neoplasms and Neoadjuvant Therapy, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy
- What is being tested?
- CEUS and blue dye
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2021to 15 Aug 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old female；
- ECOG：0 - 1；
- Biopsy confirmed invasive breast cancer；
- cT1-4N0-3；
- Signed informed consent.
Who cannot join
- Inflammatory breast cancer；
- Received ipsilateral axillary surgery previously；
- During pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Sun Yat-Sen university
Guangzhou, Guangdong, 510000
About this study
Official title: A Prospective Multi-center Study: Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy After Neoadjuvant Therapy in Breast Cancer
False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.
- Being tested
- CEUS, blue dye
- Keywords
- contrast enhanced ultrasonography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEUSProcedure or surgery
CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.
blue dyeProcedure or surgery
Before operation, blue dye is injected for sentinel lymph node mapping.
| Study group | Role | What they receive |
|---|---|---|
| CEUS+blue dye | Experimental | The included patients will accept essential tests and CEUS before and after neoadjuvant chemotherapy to evaluate axillary lymph nodes status. When patients finish neoadjuvant therapy, SLNB with or without axillary lymph node dissection will be performed using CEUS lymphatic mapping to mark SLN on the skin combined with blue dye. Receives: Procedure: CEUS; Procedure: blue dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate
The false negative rate (FNR) of sentinel lymph node biopsy using dual-tracer with CEUS and blue dye after neoadjuvant chemotherapy in invasive breast cancer patients.
The FNR is calculated as the number of false negative cases divided by the number of false negative plus true positive cases and then multiplied by 100%.
Measured: 6 months
Secondary outcomes (3)
The detective rate of sentinel lymph node biopsy
The detective rate of SLNB after neoadjuvant therapy when using blue dye and CEUS lymphatic mapping as dual tracer.
The detective rate is calculated as the number of patients in whom SLN can be detected during SLNB divided by the number of patients with the treatment of SLNB and then multiplied by 100%.
Measured: 6 months
The average numbers of sentinel lymph node
The average numbers of sentinel lymph node is calculated as the number of all SLNs detected during SLNB divided by the number of patients received SLNB and then multiplied by 100%.
Measured: 6 months
The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer
The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer patients before and after neoadjuvant therapy.
The accuracy rate is calculated as the number of true positive plus true negative cases divided by the number of patients then multiplied by 100%.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start15 Jun 2021 (estimated)
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Seventh Affiliated Hospital of Sun Yat-sen University, Affiliated Hospital of Guangdong Medical University, First Affiliated Hospital of Shantou University Medical College
- Responsible party
- Principal investigator, Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932460
- Sponsor's protocol ID
- 2021332GD
- Acronym
- Asclepius
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.
PubMed 23683750Boileau JF, Poirier B, Basik M, Holloway CM, Gaboury L, Sideris L, Meterissian S, Arnaout A, Brackstone M, McCready DR, Karp SE, Trop I, Lisbona A, Wright FC, Younan RJ, Provencher L, Patocskai E, Omeroglu A, Robidoux A. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015 Jan 20;33(3):258-64. doi: 10.1200/JCO.2014.55.7827. Epub 2014 Dec 1.
PubMed 25452445
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Study: Contrast-enhanced Ultrasonography Combined With Blue Dye as Dual-tracer for Sentinel Lymph Node Biopsy After Neoadjuvant Therapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT04932460
- Acronym / sponsor ID
- Asclepius / 2021332GD
- Keywords
- contrast enhanced ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- The Seventh Affiliated Hospital of Sun Yat-sen University, Affiliated Hospital of Guangdong Medical University, First Affiliated Hospital of Shantou University Medical College
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 21 Jun 2021 (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.
False negative rate (FNR) in patients who has accepted neoadjuvant therapy is high. Blue dye and radioisotope as dual-tracer can decrease FNR. Several large clinical trials showed that using dual trace with blue dye and radioisotope can reduce the FNR to less than 10%. But radioisotope is still not approved in China and can cause radiocontamination. A novel dual-tracer which can decrease the FNR in patients after neoadjuvant therapy is urged to be explored. Contrast enhanced ultrasonography (CEUS) can make the lymphatic drainage path and sentinel lymph nodes visible. Retrospective studies found that CEUS can locate SLN precisely. So this clinical trial aim to evaluate FNR, detective rate and numbers of SLN by using CEUS combined with blue dye as dual-tracer in sentinel lymph node biopsy in breast cancer patients after neoadjuvant therapy and the accuracy of CEUS for the diagnosis of lymph node metastasis before and after neoadjuvant therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEUS+blue dye | Experimental | Procedure: CEUS, Procedure: blue dyeThe included patients will accept essential tests and CEUS before and after neoadjuvant chemotherapy to evaluate axillary lymph nodes status. When patients finish neoadjuvant therapy, SLNB with or without axillary lymph node dissection will be performed using CEUS lymphatic mapping to mark SLN on the skin combined with blue dye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old female；
- ECOG：0 - 1；
- Biopsy confirmed invasive breast cancer；
- cT1-4N0-3；
- Signed informed consent.
Key exclusion criteria (3 listed)
- Inflammatory breast cancer；
- Received ipsilateral axillary surgery previously；
- During pregnancy.
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 |
|---|---|---|
| CEUSCEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node. | Procedure or surgery | CEUS+blue dye |
| blue dyeBefore operation, blue dye is injected for sentinel lymph node mapping. | Procedure or surgery | CEUS+blue dye |
Primary outcome
False negative rate
Time frame: 6 months
The false negative rate (FNR) of sentinel lymph node biopsy using dual-tracer with CEUS and blue dye after neoadjuvant chemotherapy in invasive breast cancer patients. The FNR is calculated as the number of false negative cases divided by the number of false negative plus true positive cases and then multiplied by 100%.
3 secondary outcomes
The detective rate of sentinel lymph node biopsy
Time frame: 6 months
The average numbers of sentinel lymph node
Time frame: 6 months
The accuracy of CEUS in evaluation of axillary lymph nodes in breast cancer
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Results publication: PubMed 23683750Kuehn T, Bauerfeind I, Fehm T, Fleige B, Hausschild M, Helms G, Lebeau A, Liedtke C, von Minckwitz G, Nekljudova V, Schmatloch S, Schrenk P, Staebler A, Untch M. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013 Jun;14(7):609-18. doi: 10.1016/S1470-2045(13)70166-9. Epub 2013 May 15.
- Results publication: PubMed 25452445Boileau JF, Poirier B, Basik M, Holloway CM, Gaboury L, Sideris L, Meterissian S, Arnaout A, Brackstone M, McCready DR, Karp SE, Trop I, Lisbona A, Wright FC, Younan RJ, Provencher L, Patocskai E, Omeroglu A, Robidoux A. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015 Jan 20;33(3):258-64. doi: 10.1200/JCO.2014.55.7827. Epub 2014 Dec 1.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEUS and blue dye in people with Breast Neoplasms and Neoadjuvant Therapy, run by First Affiliated Hospital, Sun Yat-Sen University 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 5 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: status not confirmed, as of the sponsor's last update on 21 Jun 2021. 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?
Contact Ying Lin (13076873871, linying3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False negative rate (time frame: 6 months). 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 NCT04932460, which also lists 2 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 21 Jun 2021.