Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Breast Cancer and Metastatic Lymph Nodes (FLUO)

Permanence of Indocyanine Green in Axillary Lymph Nodes 3 Weeks After Subdermal Injection in Patients With Braast Cancer and Metastatic Lymph Nodes (FLUO)

In the case of a pre-operative diagnosis of ductal carcinoma in situ (DCIS), sentinel lymph node biopsy is generally not indicated whereas it is considered standard clinical practice for patients with clinical stage I-II infiltrating breast cancer who have clinically negative axillary lymph nodes or clinically suspicious lymph nodes with negative needle aspiration findings. It is not uncommon that, in patients with ductal carcinoma in situ at preoperative diagnosis, there may be an upgrade on definitive histological examination due to the identification of foci of infiltration (about one-fifth of cases), requiring axillary lymph node biopsy in a second surgery. Prospective studies have shown that the sentinel lymph node identification rate after recent breast-conserving surgery is suboptimal. With regard to the false negative rate (FNR), several studies demonstrated that it could be associated with different techniques used for lymph node identification. Lymph node biopsy by Indocyanine green (ICG) is capable of identifying the sentinel lymph node, however, there are no data in literature on the permanence of ICG in the lymph node system. The knowledge of this data would allow the application of this method, already considered safe for the identification of the sentinel lymph node at the time of breast surgery, also in those situations in which the sentinel lymph node biopsy is postponed due to the upgrade of definitive histological diagnosis from carcinoma in situ to infiltrating/micro-infiltrating carcinoma.The main objective of this trial is to evaluate the permanence of fluorescence at the level of axillary lymph nodes 3 weeks after subcutaneous injection in patients who are candidates to radical axillary surgery. Marking the sentinel lymph node before breast surgery in cases of DCIS with risk factors could reduce the false negative rate, allowing to increase the accuracy of the procedure in identifying the lymph node potentially involved by metastatic infiltration. In addition, the identification of the sentinel lymph node in patients who are candidates to radical axillary surgery, could increase the sensitivity of the surgery in staging axillary disease and could make the lymph node exeresis more targeted, reducing the morbidity of the surgery resulting in a better outcome for the patient.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Indocyanine green

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Fracon, MD; Phone Number: 0434 659317; Email: stefano.fracon@cro.it
• Study Contact Backup: Name: Samuele Massarut, MD; Email: smassarut@cro.it

Study Locations

• Italy
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
      • Contact: Samuele Massarut, MD; Email: smassarut@cro.it
      • Contact: Stefano Fracon, MD; Phone Number: 0434659317; Email: stefano.fracon@cro.it
      • Principal Investigator: Stefano Fracon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Written informed consent must be obtained and documented before starting protocol-specific procedures and follow-up, according to local regulatory requirements.
• >18 years old
• Breast cancer patients with cyto-histologically ascertained lymph node metastases and candidates for quadrantectomy/mastectomy combined with radical axillary surgery

Exclusion Criteria:

• patients allergic to Iodine or Indocyanine Green
• patients with thyroid diseases (hyperthyroidism, autoimmune thyroid adenomas)
• patients who are not candidates for radical axillary surgery
• pregnant patients
• underage patients
• interdicted patients or patients requiring a support administrator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subdermal injection of 2,5 mg (1 cc) of ICG; Subdermal injection of 2,5 mg (1 cc) of ICG will be performed 3 weeks before surgery	Drug: Indocyanine green; Subdermal injection of 2,5 mg (1 cc) of ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Frequency of patient with at least 3 fluorescent lymph nodes	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the total number of fluorescent lymph nodes	Absolute frequency of total number of fluorescent lymph nodes per patient	up to 3 weeks
Differences in the qualitative assessment (intensity) of fluorescence between the removed lymph nodes: lymph nodes will be divided into group A "intense fluorescence" and group B "mild fluorescence"	Absolute frequency of lymph nodes in group A and in group B	up to 3 weeks
Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes	Frequency of lymph nodes with metastases resulting fluorescent	up to 3 weeks
Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes	Frequency of fluorescent and non-fluorescent lymph nodes between subgroups of patients with different demographic and clinical characteristics	up to 3 weeks

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano
• Investigators: Principal Investigator: Stefano Fracon, MD, Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CRO-2024-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No