Clinical trial · Observational
Selective Sentinella Lymph Node Biopsy with Indocyanine Green in Patients with Breast Cancer
INDOCYANINE GREEN for SELECTIVE SENTINELLA AXILLARY LYMPH NODE BIOPSY in PATIENTS with BREAST CANCER
NCT06378944CI-TRIAL-00080680INSEANrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Application of green indocyanine colorant | Other | — | UNRESOLVED |
| Technetium99 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of Sentinel lymph node detected. Scale of numbers
- timeFrame
- patients included from 1 January of 2024 til January 1 2029
- description
- Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers
Secondary outcomes (2)
- measure
- Number of possitive lymph nodes
- timeFrame
- patients included from 1 January of 2024 til January 1 2029
- description
- assess whether there are differences in affected lymph nodes detected with indocyanine green or technetium 99 Number of possitive lymph nodes iwh indocyanine green and with technetium 99
- measure
- surgery time in minutes
- timeFrame
- patients included from 1 January of 2024 til January 1 2029
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>18 years of age with breast cancer who are candidates for sentinel lymph node detection will be included. * N0 patients or patients who have undergone target axillary detection with good response Exclusion Criteria: * Lymphadenectomy
References
Publications (7)
- BACKGROUNDKrag DN, Weaver DL, Alex JC, Fairbank JT. Surgical resection and radiolocalization of the sentinel lymph node in breast cancer using a gamma probe. Surg Oncol. 1993 Dec;2(6):335-9; discussion 340. doi: 10.1016/0960-7404(93)90064-6. PMID 8130940
- BACKGROUNDGiuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015. PMID 8092905
- BACKGROUNDGoyal A, Newcombe RG, Chhabra A, Mansel RE; ALMANAC Trialists Group. Factors affecting failed localisation and false-negative rates of sentinel node biopsy in breast cancer--results of the ALMANAC validation phase. Breast Cancer Res Treat. 2006 Sep;99(2):203-8. doi: 10.1007/s10549-006-9192-1. Epub 2006 Mar 16. PMID 16541308
- BACKGROUNDKitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211. PMID 16110291
- BACKGROUNDJeremiasse B, van den Bosch CH, Wijnen MWHA, Terwisscha van Scheltinga CEJ, Fiocco MF, van der Steeg AFW. Systematic review and meta-analysis concerning near-infrared imaging with fluorescent agents to identify the sentinel lymph node in oncology patients. Eur J Surg Oncol. 2020 Nov;46(11):2011-2022. doi: 10.1016/j.ejso.2020.07.012. Epub 2020 Aug 3. PMID 32826112
- BACKGROUNDGoonawardena J, Yong C, Law M. Use of indocyanine green fluorescence compared to radioisotope for sentinel lymph node biopsy in early-stage breast cancer: systematic review and meta-analysis. Am J Surg. 2020 Sep;220(3):665-676. doi: 10.1016/j.amjsurg.2020.02.001. Epub 2020 Feb 7. PMID 32115177
- BACKGROUNDKedrzycki MS, Leiloglou M, Ashrafian H, Jiwa N, Thiruchelvam PTR, Elson DS, Leff DR. Meta-analysis Comparing Fluorescence Imaging with Radioisotope and Blue Dye-Guided Sentinel Node Identification for Breast Cancer Surgery. Ann Surg Oncol. 2021 Jul;28(7):3738-3748. doi: 10.1245/s10434-020-09288-7. Epub 2020 Nov 6.