WOMAN BREAST CANCER MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: VERDE INDOC.PULS.*INIET 5FL25M
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INDOCYANINE GREEN
CAS Number: 3599-32-4
Current Sponsor code: NA
Other descri
Sponsors
A.U.S.L. RIMINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 Histologically or cytologically confirmed diagnosis of breast cancer Early Breast cancer than or equal to 3 cm in diameter; Clinically negative axilla; Signature of Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hypersensitivity / allergy known to ICG, sodium iodide or iodine; hyperthyroidism; Thyroid cancer; Patients who are pregnant and / or lactation; Patients who are taking medicines that affect liver function; Patients with renal insufficiency; Patients who are taking drugs that may alter the absorption of green indocyanine Patients with psychiatric illness or any illness that would impair the ability to provide informed consent for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Validation of the the fluorescence lymphography with green indocyanine by comparing direct inter and intra-patients with the gold standard method the radio colloid;Secondary Objective: NA;Primary end point(s): The study aims is to demonstrate the equivalence of the two methods. It is assumed that the radioactive tracer (Gold Standard) captures at least 97% of the lymph nodes, the percentage of discrepancy between the two tests is 6% and sets the margin of equivalence of the difference in performance between the two methods to = 5% .;Timepoint(s) of evaluation of this end point: 1 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactRicerca e Innovazione
AUSL Rimini
Outcome results
None listed