ICG-fluorescence Imaging for Intraoperative Breast Cancer Margins Evaluation: a Dose-timing Study

NCT06227338 | Recruiting

• 1 other identifier: IJB-S2022-IFIBC01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Designed in five-arm, single-center, prospective randomized, observational- interventional, open-label study which will evaluate patients with histological proven early-stage BC that will undergo planned BCS for their local treatment. Two preoperatively times frames will be used for the administration of a total of 5 different indocyanine green (ICG) dose as a single dose-patient arm. In the first time frame (intraoperative arms), the dose of, respectively 0.125 mg/kg and 0.25 mg/kg of ICG will be administered at induction anesthesia (at least 20 minutes before the BCS) in two subgroups. In the second time frame, (preoperative arms), the dose of, respectively, 0.5 mg/kg, 1 mg/kg, and 2 mg/kg of ICG will be administered 24 h before surgery in 3 subgroups.

Conditions

Breast Cancer

Keywords

Breast cancer; Conservative surgery; Indocyanine Green

Outcome Measures

Primary Outcomes (1)

• Accuracy of ICG-FI technique for the detection of positive (involved) surgical margins at the patient level

  The sensitivity (Se), specificity (Sp), negative predictive value (NPV), false negative rate (FNR), FPR of the ICG-FI technique will be computed at the patient level

  2 years

Secondary Outcomes (3)

• Comparison of ICG-FI technique accuracy at different doses and timing

  2 years

• Characterization of the breast tumor fluorescence (tumor-to- background fluorescence ratio)

  2 years

• Evaluation of fluorescence intensity of axillary lymph nodes

  2 years

Study Arms (5)

0.125 mg/kg

EXPERIMENTAL

Patients who will be injected with 0.125 mg/kg Indocyanine green before their tumorectomy

Drug: Indocyanine green

0.25 mg/kg

EXPERIMENTAL

Patients who will be injected with 0.25 mg/kg Indocyanine green before their tumorectomy

Drug: Indocyanine green

0.5 mg/kg

EXPERIMENTAL

Patients who will be injected with 0.5 mg/kg Indocyanine green before their tumorectomy

Drug: Indocyanine green

1 mg/kg

EXPERIMENTAL

Patients who will be injected with 1 mg/kg Indocyanine green before their tumorectomy

Drug: Indocyanine green

2 mg/kg

EXPERIMENTAL

Patients who will be injected with 2 mg/kg Indocyanine green before their tumorectomy

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter: * at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or * in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).

0.125 mg/kg; 0.25 mg/kg; 0.5 mg/kg; 1 mg/kg; 2 mg/kg

Eligibility Criteria

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

You may qualify if:

• female;
• age of ≥18 years;
• histological diagnosis of ductal invasive breast cancer;
• a primary early-stage invasive breast cancer (cT1 and/or cT2, assessed clinically and/or radiologically), without prior BC surgery of the actually affected breast;
• ECOG Performance Status (PS) 0 or 1;
• signed informed consent form (ICF) obtained prior to any study related procedure.

You may not qualify if:

• advanced invasive breast cancer (cT3 and/or cT4);
• in situ breast cancer disease;
• lobular invasive breast cancer (at histology);
• invasive breast cancer treated by neoadjuvant chemotherapy and/or endocrine therapy;
• prior history of invasive or breast cancer of the actually affected breast in the past;
• history of allergy or hypersensitivity to investigational product (active substance or ingredients);
• history of allergy to iodine or to shellfish;
• have apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal, or disseminated autonomy of the thyroid gland;
• documented coronary disease
• advanced renal insufficiency (serum creatinine \>1.5 mg/dL);
• chronic liver disease with the Child-Pugh class B or C ;
• concurrent medication which reduces or increases the elimination of indocyanine green dye (ie, anticonvulsants, haloperidol, and heparin) during the 2 weeks before the expected operation;
• pregnant or lactating women;
• inability to give informed consent.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, 1070, Belgium

RECRUITING

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

• Florin Pop, MD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florin Pop, MD

CONTACT

+322541; catalin.florin.pop@hubruxelles.be

Study Design

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

Model Details: Indocyanine green dye (Diagnostic Green) will be diluted with sterile water and a specific dose-arm (0.125 mg/kg, 0.25 mg/kg, 05 mg/kg, 1 mg/kg, and 2 mg/kg) will be administrated by slow intravenous injection by peripheral venous catheter: * at induction anaesthesia of the surgical procedure (0.125 mg/kg or 0.25mg/kg), or * in the hospital room 24 hours before the breast surgery (05 mg/kg, or 1 mg/kg, or 2 mg/kg).

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: January 26, 2024
• Study Start: February 12, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2024-09

Locations

BE (1)