Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity
NCT ID: NCT02994225
Last Updated: 2022-05-16
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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COMPLETED
NA
120 participants
INTERVENTIONAL
2017-03-10
2019-08-05
Brief Summary
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The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study arm
Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
Near Infra-red images acquisition is performed during surgery
Indocyanine Green
Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
Near Infra-red images acquisition is performed during surgery
Interventions
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Indocyanine Green
Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
Near Infra-red images acquisition is performed during surgery
Eligibility Criteria
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Inclusion Criteria
* Preoperative diagnosis of Invasive breast cancer
* Patient deemed for total mastectomy with axillary lymph node dissection (ALND)
* Subject capable of giving informed consent and participating in the process of consent
* Affiliated to the french social security
Exclusion Criteria
* Previous ipsilateral axillary radiotherapy
* Previous axillary surgery
* Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
* Breastfeeding
* Allergy to indocyanine green
* Patients with a known history of reaction to iodine or iodine-containing compounds.
* No consent
* Impaired capacity to make informed medical decisions
* Patient on guardianship
18 Years
FEMALE
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Principal Investigators
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Chafika MAZOUNI, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Gustave Roussy
Villejuif, Val De Marne, France
Countries
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References
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Conversano A, Abbaci M, Karimi M, Mathieu MC, de Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Axillary reverse mapping using near-infrared fluorescence imaging in invasive breast cancer (ARMONIC study). Eur J Surg Oncol. 2022 Dec;48(12):2393-2400. doi: 10.1016/j.ejso.2022.07.004. Epub 2022 Jul 8.
Abbaci M, Conversano A, Karimi M, Mathieu MC, Rouffiac V, De Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Near-Infrared Fluorescence Axillary Reverse Mapping (ARM) Procedure in Invasive Breast Cancer: Relationship between Fluorescence Signal in ARM Lymph Nodes and Clinical Outcomes. Cancers (Basel). 2022 May 25;14(11):2614. doi: 10.3390/cancers14112614.
Other Identifiers
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2016/2462
Identifier Type: OTHER
Identifier Source: secondary_id
2016-A01623-48
Identifier Type: -
Identifier Source: org_study_id
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