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Status unknownNCT02869815Updated May 29, 2019

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

An observational study in Breast Neoplasms, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-29.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
20 Years to 80 Years
Sex
Female
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Study 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.

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.

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Conditions studied

  • Breast Neoplasms

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Keywords

  • Methylene blue
  • Indocyanine green
  • Neoadjuvant Therapy
  • Sentinel Lymph Node Biopsy
  • Breast Neoplasms
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In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 150 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureICG+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.

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What researchers measure

Primary outcomes

  1. Detection rate of SLN

    The number of successful SLNB / total number of SLNB

    Time frame: Immediate

Secondary outcomes

  1. False negative rate of SLNB

    The number of patients with positive SLN / the number of patients with positive node

    Time frame: 1 week after the surgery

  2. Adverse effect

    Prophylaxis reaction, skin complication

    Time frame: Half a year after the surgery

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Study locations

1 of 1 sites recruiting
  • Breast Center, Peking University People's Hospital
    Beijing, Beijing 100044, China
    • Houpu Yang, M.D. · Contact · yanghoupu@pkuph.edu.cn · 8610-88324010
    • Shu Wang, M.D. · Principal investigator
    Recruiting
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References and documents

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 23683750 ↗
  • 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. PubMed 24101169 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02869815
Lead sponsor
Peking University People's Hospital
Responsible party
Sponsor
First posted
Aug 17, 2016
Start date
Aug 2016
Primary completion
Aug 2019 (estimated)
Completion
Aug 2020 (estimated)
Last update
May 29, 2019

Study contacts

Houpu Yang, M.D.
Contact
yanghoupu@pkuph.edu.cn
+86-10-88324010
Shu Wang, M.D.
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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