Clinical trial · Interventional
Study of the ICG Distribution in the Margins of Breast Cancer After Tumorectomy
Study of the (Intravenously Injected) Indocyanine Green Distribution in the Margins of Breast Cancer After Tumorectomy
NCT02027818CI-TRIAL-00072314completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We will observe if ICG fluorescence correlates with margins of breast tumours after iv injection of the contrast agent
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Indocyanine Green
- description
- study of the correlation between fluorescence and margins of the tumours after iv injection of Indocyanine Green
- interventionNames
- Drug: Indocyanine Green
Primary outcomes (1)
- measure
- - Evaluation of the ability of NIR imaging to show (fluorescent) the tumoral volumes, the tumoral tissues to be analyzed by the pathologist, especially at the level of the operative margins
- timeFrame
- 17 months
Secondary outcomes (1)
- measure
- - Analysis of the correlation between (levels of) ICG fluorescence and tumour margins as defined at the microscopic level by the pathologist
- timeFrame
- 17 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histopathological diagnosis of mammary cancer who are candidate for tumorectomy, either with SLN selective lymphadenectomy, or with complete axillary node dissection, * Informed consent form signed. Exclusion Criteria: * Diagnosis of mammary cancer established by "gross" biopsy, * Age less than18 years old. * Inability to give informed consent. * History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish. * Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland. * Documented coronary disease. * Advanced renal impairment (creatinine \> 1,5mg/dl). * During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin). * Pregnancy, breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.