Clinical trial NCT02869815: ICG and Blue Dye Guided Sentinel Lymph Node Biopsy in Patients Underwent Neoadjuvant Therapy
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Keywords: Methylene blue
Indocyanine green
Neoadjuvant Therapy
Sentinel Lymph Node Biopsy
Breast Neoplasms
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with large operable or locally advanced breast cancer underwent neoadjuvant therapy.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection rate of SLN
timeFrame: Immediate
Secondary outcomes:
measure: False negative rate of SLNB
timeFrame: 1 week after the surgery
measure: Adverse effect
timeFrame: Half a year after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Breast Center, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Shu Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.