Search / Trial NCT06227338

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

Launched by JULES BORDET INSTITUTE · Jan 24, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Breast Cancer Conservative Surgery Indocyanine Green

ClinConnect Summary

This clinical trial is studying a special imaging technique called ICG-fluorescence imaging, which helps doctors see if breast cancer has been completely removed during surgery. The trial is specifically for women aged 18 and older who have been diagnosed with early-stage invasive breast cancer and are planning to have breast-conserving surgery. Participants will receive different doses of a dye called indocyanine green (ICG) either right before their surgery or 24 hours in advance. The goal is to find out the best timing and dose of the dye to ensure clear images during the operation.

To be eligible for this trial, women must have a specific type of breast cancer and have not had prior surgery on the affected breast. There are also certain health conditions and allergies that would exclude someone from participating. Those who join the study can expect to receive the dye and then have their surgery, during which doctors will use the imaging technique to help guide the procedure. If you're considering participating, it’s important to fully understand the process and discuss any questions with your healthcare provider.

Gender

FEMALE

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.

Trial Officials

Florin Pop, MD

Principal Investigator

Jules Bordet Institute

About Jules Bordet Institute

The Jules Bordet Institute is a prestigious cancer research and treatment center located in Brussels, Belgium, dedicated to advancing oncology through innovative clinical trials and multidisciplinary care. As a leading sponsor of clinical research, the institute focuses on developing novel therapeutic approaches and improving patient outcomes in various cancer types. With a commitment to scientific excellence and collaboration, the Jules Bordet Institute leverages cutting-edge technologies and a robust network of healthcare professionals to foster breakthroughs in cancer treatment and enhance the quality of life for patients.

Locations

Brussels, , Belgium

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0