ICG and Blue Dye Guided Sentinel Lymph Node Biopsy in Patients Underwent Neoadjuvant Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms
• Intervention / Treatment: Procedure: ICG+Methylene Blue

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Houpu Yang, M.D.; Phone Number: +86-10-88324010; Email: yanghoupu@pkuph.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Breast Center, Peking University People's Hospital
      • Contact: Houpu Yang, M.D.; Phone Number: 8610-88324010; Email: yanghoupu@pkuph.edu.cn
      • Principal Investigator: Shu Wang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of SLN	The number of successful SLNB / total number of SLNB	Immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
False negative rate of SLNB	The number of patients with positive SLN / the number of patients with positive node	1 week after the surgery
Adverse effect	Prophylaxis reaction, skin complication	Half a year after the surgery

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: shu wang, M.D., Peking University People's Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ANTICIPATED): August 1, 2019
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (ESTIMATE): August 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 26, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Methylene blue; Neoadjuvant Therapy; Breast Neoplasms; Indocyanine green; Sentinel Lymph Node Biopsy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: PKUPHSLN003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No