Breast NeoplasmsNCT02869815
ICG and Blue Dye Guided Sentinel Lymph Node Biopsy in Patients Underwent Neoadjuvant Therapy
An observational study of Breast Neoplasms, run by Peking University People's Hospital at 1 site in China.
Trial summary
The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- ICG+Methylene Blue
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2020
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with large operable or locally advanced breast cancer underwent neoadjuvant therapy.
Who may be able to join
- Patients indicated for neoadjuvant therapy
- Have complete evaluation of the axillary status
- Planned for axillary clearance after neoadjuvant therapy
Who cannot join
- Sensitive to Iodine
- Inflammatory disease
- Patient's refusal to join the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Breast Center, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Houpu Yang, M.D., 8610-88324010, yanghoupu@pkuph.edu.cn
Shu Wang, M.D.
About this study
Official title: Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy Using the Navigation of the Combination of Indocyanine and Blue Dye in Patients With Breast Cancer
The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. The purpose of this study is to determine the detection rate and the false negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. This is a single arm clinical trial.
Read the detailed description
Patients indicated for neoadjuvant therapy would be recruited in this study. During the surgery, SLNB using the dual tracing method would be applied before axillary clearance. After the surgery, histological results of the SLN and non-SLN would be analysed.
- Conditions
- Breast Neoplasms
- Being tested
- ICG+Methylene Blue
- Keywords
- Methylene blue, Indocyanine green, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy, Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG+Methylene BlueProcedure or surgery
ICG+Methylene Blue Arm:
One ml of methylene blue (1%) would be in injected sub-areolarly 5 minutes before surgery, and 1ml of ICG (0.125%) in the same site 3 minutes later. Massage of the breast would be applied to facilitate the movement of the tracers. A small incision would be made in the axilla, and a special device would be used to search the light nodes. During the sampling, blue nodes would also be resected . After the completion of SLNB, complete axillary dissection would be carried out.
| Study group | Role | What they receive |
|---|---|---|
| ICG+Methylene Blue | ICG+Methylene Blue:
Sentinel Lymph Node (SLN) identification and resection using dual tracer technique with the sub-areolar injection of ICG+Blue dye, before surgery. Receives: Procedure: ICG+Methylene Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of SLN
The number of successful SLNB / total number of SLNB
Measured: Immediate
Secondary outcomes (2)
False negative rate of SLNB
The number of patients with positive SLN / the number of patients with positive node
Measured: 1 week after the surgery
Adverse effect
Prophylaxis reaction, skin complication
Measured: Half a year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu Wang, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869815
- Sponsor's protocol ID
- PKUPHSLN003
- Status last verified
- May 2019
- First submitted
- 29 Jul 2016
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 23683750Boughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932.
PubMed 24101169Liu M, Yang Y, Hua B, Feng R, Xu T, Wang M, Qi X, Cao Y, Zhou B, Tong F, Liu P, Liu H, Cheng L, Yang H, Xie F, Wang S, Wang C, Peng Y, Shen D, Chen L, Jiang J, Wang S. Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study. Thorac Cancer. 2025 Jan;16(2):e15511. doi: 10.1111/1759-7714.15511. Epub 2024 Dec 27.
PubMed 39731298
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy Using the Navigation of the Combination of Indocyanine and Blue Dye in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT02869815
- Acronym / sponsor ID
- PKUPHSLN003
- Conditions
- Breast Neoplasms
- Keywords
- Methylene blue, Indocyanine green, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy, Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 17 Aug 2016 (estimated)
- 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 value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. The purpose of this study is to determine the detection rate and the false negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. This is a single arm clinical trial.
Detailed description
Patients indicated for neoadjuvant therapy would be recruited in this study. During the surgery, SLNB using the dual tracing method would be applied before axillary clearance. After the surgery, histological results of the SLN and non-SLN would be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG+Methylene Blue | – | Procedure: ICG+Methylene BlueICG+Methylene Blue: Sentinel Lymph Node (SLN) identification and resection using dual tracer technique with the sub-areolar injection of ICG+Blue dye, before surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with large operable or locally advanced breast cancer underwent neoadjuvant therapy.
Key inclusion criteria (3 listed)
- Patients indicated for neoadjuvant therapy
- Have complete evaluation of the axillary status
- Planned for axillary clearance after neoadjuvant therapy
Key exclusion criteria (3 listed)
- Sensitive to Iodine
- Inflammatory disease
- Patient's refusal to join the trial
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 |
|---|---|---|
| ICG+Methylene BlueICG+Methylene Blue Arm: One ml of methylene blue (1%) would be in injected sub-areolarly 5 minutes before surgery, and 1ml of ICG (0.125%) in the same site 3 minutes later. Massage of the breast would be applied to facilitate the movement of the tracers. A small incision would be made in the axilla, and a special device would be used to search the light nodes. During the sampling, blue nodes would also be resected . After the completion of SLNB, complete axillary dissection would be carried out. | Procedure or surgery | ICG+Methylene Blue |
Primary outcome
Detection rate of SLN
Time frame: Immediate
The number of successful SLNB / total number of SLNB
2 secondary outcomes
False negative rate of SLNB
Time frame: 1 week after the surgery
Adverse effect
Time frame: Half a year after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Background: 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.
- Background: PubMed 24101169Boughey JC, Suman VJ, Mittendorf EA, Ahrendt GM, Wilke LG, Taback B, Leitch AM, Kuerer HM, Bowling M, Flippo-Morton TS, Byrd DR, Ollila DW, Julian TB, McLaughlin SA, McCall L, Symmans WF, Le-Petross HT, Haffty BG, Buchholz TA, Nelson H, Hunt KK; Alliance for Clinical Trials in Oncology. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013 Oct 9;310(14):1455-61. doi: 10.1001/jama.2013.278932.
- Derived from this study: PubMed 39731298Liu M, Yang Y, Hua B, Feng R, Xu T, Wang M, Qi X, Cao Y, Zhou B, Tong F, Liu P, Liu H, Cheng L, Yang H, Xie F, Wang S, Wang C, Peng Y, Shen D, Chen L, Jiang J, Wang S. Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study. Thorac Cancer. 2025 Jan;16(2):e15511. doi: 10.1111/1759-7714.15511. Epub 2024 Dec 27.
- 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, M.D. 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?
An observational study of 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: status not confirmed, as of the sponsor's last update on 29 May 2019. 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 Houpu Yang, M.D. (+86-10-88324010, yanghoupu@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of SLN (time frame: Immediate). 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 NCT02869815, which also lists 3 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 29 May 2019.