Validation of the use of green indocyanine in identifying the sentinel node in breast cancer

Active, not recruiting

• Conditions: WOMAN BREAST CANCER; MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000513-36-IT
• Lead Sponsor: A.U.S.L. RIMINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified