Using ICG-fluorescence imaging to evaluate breast cancer surgery margins

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

This study is testing if a special imaging technique using a dye can help doctors see the edges of breast tumors better during surgery to make sure they remove all the cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Jules Bordet Institute (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Brussels)
• Trial ID: NCT06227338 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of indocyanine green (ICG) fluorescence imaging in assessing surgical margins during breast-conserving surgery for early-stage breast cancer. It is a five-arm, single-center, prospective randomized observational-interventional study where patients will receive different doses of ICG either preoperatively or intraoperatively. The goal is to improve the accuracy of tumor detection and ensure adequate margins of excision, which is crucial for successful surgical outcomes. The study aims to provide real-time guidance during surgery to enhance the delineation between normal and tumoral tissues.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 and older with histologically confirmed early-stage invasive ductal breast cancer.

Not a fit: Patients with advanced invasive breast cancer, in situ breast cancer, or those who have received prior treatment for breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate surgical margins and better outcomes for patients undergoing breast-conserving surgery.

How similar studies have performed: While there have been limited prior studies using ICG-fluorescence imaging for breast cancer, the approach shows promise based on experiences in other cancers, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. female;
2. age of ≥18 years;
3. histological diagnosis of ductal invasive breast cancer;
4. 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;
5. ECOG Performance Status (PS) 0 or 1;
6. signed informed consent form (ICF) obtained prior to any study related procedure.

Exclusion Criteria:

1. advanced invasive breast cancer (cT3 and/or cT4);
2. in situ breast cancer disease;
3. lobular invasive breast cancer (at histology);
4. invasive breast cancer treated by neoadjuvant chemotherapy and/or endocrine therapy;
5. prior history of invasive or breast cancer of the actually affected breast in the past;
6. history of allergy or hypersensitivity to investigational product (active substance or ingredients);
7. history of allergy to iodine or to shellfish;
8. have apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal, or disseminated autonomy of the thyroid gland;
9. documented coronary disease
10. advanced renal insufficiency (serum creatinine \>1.5 mg/dL);
11. chronic liver disease with the Child-Pugh class B or C ;
12. 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;
13. pregnant or lactating women;
14. inability to give informed consent.

Where this trial is running

Brussels

• Jules Bordet Institute — Brussels, Belgium (Recruiting)

Study contacts

• Principal investigator: Florin Pop, MD — Jules Bordet Institute
• Study coordinator: Florin Pop, MD

Conditions Breast Cancer; Breast cancer; Conservative surgery; Indocyanine Green