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

NCT06347354 | Not Yet Recruiting

• 1 other identifier: CRO-2024-15
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Identification of the total number of fluorescent lymph nodes

  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"

  up to 3 weeks

• Association between histological positivity for metastases in sentinel and non-sentinel lymph nodes

  up to 3 weeks

• Association between the patient's demographic/clinical variables and the presence or absence of fluorescent lymph nodes

  up to 3 weeks

Study Arms (1)

Subdermal injection of 2,5 mg (1 cc) of ICG

EXPERIMENTAL

Subdermal injection of 2,5 mg (1 cc) of ICG will be performed 3 weeks before surgery

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

Subdermal injection of 2,5 mg (1 cc) of ICG

Subdermal injection of 2,5 mg (1 cc) of ICG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

Aviano, Pordenone, 33081, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stefano Fracon, MD

  Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Fracon, MD

CONTACT

0434 659317; stefano.fracon@cro.it

Samuele Massarut, MD

CONTACT

smassarut@cro.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-03

Locations

IT (1)