INDOCYANINE GREEN for Breast cancer

Inclusion criteria

• {"criterion_text":"- Written informed consent prior to beginning any protocol specific procedure during treatment and follow up, according to regulatory requirements."}
• {"criterion_text":"- Age equal to or higher than 18 years"}
• {"criterion_text":"- Patients affeted by breast cancer with cyto-histological confirmation of lymph node metastases and eligible for quadrantectomy/mastectomy combined with radical axillary surgery."}

Exclusion criteria

• {"criterion_text":"- Allergy to iodium or Indocyanine Green"}
• {"criterion_text":"- Presence of Thyroid disorders (hyperthyroidism, autoimmune thyroid adenomas)"}
• {"criterion_text":"- Patients not eligible for radical axillary surgery"}
• {"criterion_text":"- Patient in a state of pregnancy"}
• {"criterion_text":"- Under the age of 18 years"}
• {"criterion_text":"- Non-autonomous patient or in need of a legal representative"}

Primary endpoints

• {"endpoint_text":"- Frequency of patient with at least 3 fluorescent lymph nodes","definition_or_measurement_approach":"Measured as the frequency (proportion) of patients having at least 3 fluorescent axillary lymph nodes assessed at 2-3 weeks after subcutaneous injection of Indocyanine Green and evaluated during radical axillary surgery (Time Frame: up to 3 weeks)."}

Secondary endpoints

• {"endpoint_text":"- Absolute frequency of total number of fluorescent lymph nodes per patient","definition_or_measurement_approach":"Identification/counting of the total number of fluorescent lymph nodes per patient."}
• {"endpoint_text":"- Absolute frequency of lymph nodes in group A and in group B","definition_or_measurement_approach":"Classification of removed lymph nodes into group A (\"intense fluorescence\") and group B (\"mild fluorescence\") and reporting absolute frequencies per group."}
• {"endpoint_text":"- Frequency of lymph nodes with metastases resulting fluorescent","definition_or_measurement_approach":"Assessment of histological positivity for metastases in lymph nodes and reporting frequency of those metastatic nodes that are fluorescent."}
• {"endpoint_text":"- Frequency of fluorescent and non-fluorescent lymph nodes between subgroups of patients with different demographic and clinical characteristics","definition_or_measurement_approach":"Comparison of frequencies of fluorescent vs non-fluorescent lymph nodes across patient subgroups defined by demographic/clinical variables."}

Italy

Earliest CTIS Part Ii Submission Date

13-08-2024

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

573

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Centro Di Riferimento Oncologico Di Aviano

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy