ICG and Blue Dye Guided Sentinel Lymph Node Biopsy in Patients Underwent Neoadjuvant Therapy
NCT ID: NCT02869815
Last Updated: 2019-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2016-08-31
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Have complete evaluation of the axillary status
* Planned for axillary clearance after neoadjuvant therapy
Exclusion Criteria
* Inflammatory disease
* Patient's refusal to join the trial
20 Years
80 Years
FEMALE
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Shu Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Breast Center, Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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PKUPHSLN003
Identifier Type: -
Identifier Source: org_study_id
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