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 October 08, 2024

Recruiting

Keywords

Breast Cancer Conservative Surgery Indocyanine Green

Description

The majority of breast cancer (BC) patients are diagnosed with an early-stage disease and are good candidates for breast-conserving surgery (BCS). Achieving adequate margins of excision is the most important component of BCS. Currently intra-operative margin assessment (IOMA) techniques used for margins evaluation in BC, either histological or imagistic is not accurate enough to predict the margins status of breast resected tumours and to guide surgery. Fluorescence imaging (FI) using indocyanine green (ICG), a non-specific fluorophore, has also been reported to be a new, promising, non-in...

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.

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