NCT02869815

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

July 29, 2016

Last Update Submit

May 26, 2019

Conditions

Breast Neoplasms

Keywords

Methylene blueIndocyanine greenNeoadjuvant TherapySentinel Lymph Node BiopsyBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Detection rate of SLN

    The number of successful SLNB / total number of SLNB

    Immediate

Secondary Outcomes (2)

  • False negative rate of SLNB

    1 week after the surgery

  • Adverse effect

    Half a year after the surgery

Study Arms (1)

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.

Procedure: ICG+Methylene Blue

Interventions

ICG+Methylene BluePROCEDURE

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.

ICG+Methylene Blue

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with large operable or locally advanced breast cancer underwent neoadjuvant therapy.

You may qualify if:

  • Patients indicated for neoadjuvant therapy
  • Have complete evaluation of the axillary status
  • Planned for axillary clearance after neoadjuvant therapy

You may not qualify if:

  • Sensitive to Iodine
  • Inflammatory disease
  • Patient's refusal to join the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast Center, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23683750BACKGROUND

  • Boughey 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.

    PMID: 24101169BACKGROUND

  • Liu 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.

    PMID: 39731298DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shu Wang, M.D.

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Houpu Yang, M.D.

CONTACT

+86-10-88324010yanghoupu@pkuph.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 17, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2020

Last Updated

May 29, 2019

Record last verified: 2019-05

Locations

CN(1)