- Identification of the sentinel node in breast cancer with fluorescence lymphography using indocyanine green dye (ICG): pilot study.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021815-18-IT

Enrollment

255

Registered

2012-05-02

Start date

2011-06-16

Completion date

Unknown

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BREAST CANCER MedDRA version: 14.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: VERDE INDOC.PULS.*INIET 5FL25M Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: indocyanine green dye Concentration unit: mg/ml milligram(s)/millilitre Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years; - Cytologically or histologically diagnosis of breast cancer; - Primary tumor with a diameter = 3 cm; - Negative clinical evaluation of axilla; - Signed 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 255 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Hypersensitivity / known allergy to ICG, sodium iodide or iodine; - Hyperthyroidism; - Thyroid carcinoma; - Pregnancy and / or lactation; - Taking drugs that affect liver function; - Renal failure; - Taking medications that can alter the absorption of indocyanine-green; - Psychiatric disorders or any disease that compromises the ability to provide informed consent for participation in this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: validation of new method, the fluorescence lymphography by comparison with the gold standard method, the radio colloid;Secondary Objective: ;Primary end point(s): - Validation of the new method, the fluorescence lymphography, by direct comparison with the gold standard method, the radio colloid. It will be calculated the Predictive Positive Value as the LS identified percentage both through ICG and gold standard on the LS value identified through ICG . We will calculated the new diagnostic approach Sensitivity ICG as the percentage of LS identified both through ICG and gold standard on the LS value identified through gold standard .;Timepoint(s) of evaluation of this end point: after the histological evaluation of the linfonodes	—

Measure

Time frame

Main Objective: validation of new method, the fluorescence lymphography by comparison with the gold standard method, the radio colloid;Secondary Objective: ;Primary end point(s): - Validation of the new method, the fluorescence lymphography, by direct comparison with the gold standard method, the radio colloid. It will be calculated the Predictive Positive Value as the LS identified percentage both through ICG and gold standard on the LS value identified through ICG . We will calculated the new diagnostic approach Sensitivity ICG as the percentage of LS identified both through ICG and gold standard on the LS value identified through gold standard .;Timepoint(s) of evaluation of this end point: after the histological evaluation of the linfonodes

—

Secondary

Measure	Time frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -	—

Countries

Italy

Contacts

Public ContactUfficio studi clinici

Istituto Europeo Oncologia

ufficio.studiclinici@ieo.it02 57 48 98 48

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026