Permanence of Indocyanine Green in axillary lymph nodes three weeks after subdermal injection in patients with Breast Carcinoma and metastatic lymph nodes: The FLUO Trial

Phase 2

Not yet recruiting

Conditions: Breast Cancer

Registration Number: 2024-513163-57-00

Lead Sponsor: Centro Di Riferimento Oncologico Di Aviano

Brief Summary: Permanence of fluorescence at the level of axillary lymph nodes at 2-3 weeks after subcutaneous injection of Indocyanine Green (2.5 mg), in patients who will undergo radical axillary surgery [Time Frame: up to 3 weeks]

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Female

Target Recruitment: 10

Inclusion Criteria

Written informed consent prior to beginning any protocol specific procedure during treatment and follow up, according to regulatory requirements.

Age equal to or higher than 18 years

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

Allergy to iodium or Indocyanine Green

Presence of Thyroid disorders (hyperthyroidism, autoimmune thyroid adenomas)

Patients not eligible for radical axillary surgery

Patient in a state of pregnancy

Under the age of 18 years

Non-autonomous patient or in need of a legal representative

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of patient with at least 3 fluorescent lymph nodes		Frequency of patient with at least 3 fluorescent lymph nodes

Secondary Outcome Measures

Name	Time	Method
Frequency of fluorescent and non-fluorescent lymph nodes between subgroups of patients with different demographic and clinical characteristics		Frequency of fluorescent and non-fluorescent lymph nodes between subgroups of patients with different demographic and clinical characteristics
Absolute frequency of total number of fluorescent lymph nodes per patient		Absolute frequency of total number of fluorescent lymph nodes per patient
Absolute frequency of lymph nodes in group A and in group B		Absolute frequency of lymph nodes in group A and in group B
Frequency of lymph nodes with metastases resulting fluorescent		Frequency of lymph nodes with metastases resulting fluorescent

Trial Locations

Locations (1): Centro Di Riferimento Oncologico Di Aviano
🇮🇹
Aviano, Italy
Centro Di Riferimento Oncologico Di Aviano
🇮🇹Aviano, Italy
Stefano Fracon
Site contact
+390434659317
stefano.fracon@cro.it