Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer
NCT ID: NCT02875626
Last Updated: 2019-07-05
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
80 participants
INTERVENTIONAL
2016-09-30
2019-03-31
Brief Summary
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Detailed Description
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Screening:
Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month.
Intervention:
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
The search or sentinel node will be made using a infrared camera for transcutaneous visualization Secondly, data lymphoscintigraphy may be communicated to the surgeon. The nodes are identified as SN fluorescent nodes and / or radioactive nodes.
* All radioactive nodes and / or fluorescent will be deleted
* Reports of anatomy fluorescent SN and / or hot
Next visit:
The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Infracyanine
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
Infracyanine
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
Interventions
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Infracyanine
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
3. Diagnosis confirmed by biopsy
4. Breast cancer extended in situ
5. First surgical treatment
Exclusion Criteria
2. Multicentric tumor
3. Pregnant patient
4. Ongoing participation in another clinical trial with an investigational drug
18 Years
FEMALE
No
Sponsors
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Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
OTHER
Responsible Party
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Principal Investigators
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Charlotte NGO, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Européen Georges-Pompidou
Locations
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Hôpital Européen Georges Pompidou
Paris, , France
Countries
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References
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Ngo C, Sharifzadehgan S, Lecurieux-Lafayette C, Belhouari H, Rousseau D, Bonsang-Kitzis H, Crouillebois L, Balaya V, Oudard S, Lecuru F, Elaidi RT. Indocyanine green for sentinel lymph node detection in early breast cancer: Prospective evaluation of detection rate and toxicity-The FLUOBREAST trial. Breast J. 2020 Dec;26(12):2357-2363. doi: 10.1111/tbj.14100. Epub 2020 Oct 22.
Other Identifiers
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FLUOBREAST
Identifier Type: -
Identifier Source: org_study_id
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