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ICG-fluorescence imaging for intraoperative breast cancer margins evaluation: a dose-timing study
EU CTIS ID: 2023-504024-26-00
What this study is testing
To select the best strategy (timing for imaging and ICG dose) for surgical margins evaluation by intraoperative ICG-FI during breast conserving surgery in patients treated for primary invasive BC, with an adequate negative predictive value.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 likely can't join if
- Advanced invasive breast cancer cT3 and/or cT4
- 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
See the full eligibility criteria
- 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
- Advanced invasive breast cancer cT3 and/or cT4
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.