Evaluate the Implementation of Using Indocyanine Green for Sentinel Lymph Node Mapping in Breast Cancer Patients

NCT07441733 | Recruiting DMC

• 1 other identifier: 418CET
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This single-institution pilot study uses a pre- and post-implementation design to evaluate the implementation of ICG fluorescent imaging for sentinel lymph node biopsy (SLNB) in an Italian hospital.

Conditions

Breast Cancer

Keywords

breast cancer; lymph node; 99mTc; ICG

Outcome Measures

Primary Outcomes (1)

• Identification rate of SLNs achieved by 99mTc-nanocolloid or the fluorescent signal of ICG

  measure the percentage of sentinel lymph nodes identified by the 99mTc nanocolloid or the ICG fluorescent signal (%)

  through study completion, an average of 1 year

Secondary Outcomes (6)

• Percentage of SLNs that has 99mTc uptake/ is fluorescent

  through study completion, an average of 1 year

• Detection time

  through study completion, an average of 1 year

• Total operative time

  through study completion, an average of 1 year

• Number of complications and (serious) adverse events

  through study completion, an average of 1 year

• loco regional recurrence after 1 year follow-up

  through study completion, an average of 1 year

Study Arms (2)

99mTc

ACTIVE COMPARATOR

radioisotope technetium technique will be used for sentinel lymph node localization(99mTc)

Procedure: technetium 99 used as a tracer for sentinel lymph node

ICG

EXPERIMENTAL

indocyanine green fluorescent imaging technique will be used for sentinel lymph node localization (ICG)

Procedure: ICG used as a tracer for sentinel lymph node

Interventions

ICG used as a tracer for sentinel lymph node PROCEDURE

ICG used as a tracer for sentinel lymph node instead of technetium 99

ICG

technetium 99 used as a tracer for sentinel lymph node PROCEDURE

technetium 99 used as a tracer for sentinel lymph node instead of ICG

99mTc

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically node-negative, DCIS or invasive stage T1-T3 breast cancer confirmed by biopsy
• Preoperative axillary ultrasound to confirm clinical node-negative status
• Indication for breast cancer surgery with SLNB via axillar incision
• Written informed consent according to national regulations

You may not qualify if:

• Patients \< 18 years old.
• Indication for breast cancer surgery with SLNB via mastectomy incision
• Known allergy for ICG, intravenous contrast or iodine
• History of axillary lymph node dissection
• Pregnancy or breast-feeding
• Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol

Sponsors & Collaborators

• Casa di Cura Dott. Pederzoli: lead

Study Sites (1)

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The golden standard for obtaining the sentinel lymph node (SLN) in patients with breast cancer currently is radio guided surgery with radioisotope technetium (99mTc). However, the use of 99mTc-nanocolloid presents logistical challenges and contributes to patient burden. A proven effective and safe alternative is fluorescence imaging using indocyanine green (ICG).

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 2, 2026
• Study Start: November 7, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)