Clinical trial · Interventional
ICG Distribution Using NIF Imaging After IV Injection of ICG in Benign and Malignant Breast Cancer Tissue.
Histological Study of the (Intravenously Injected) ICG Distribution in Tumor Bearing Breasts and in Axillary Pieces of Dissection.
NCT01993576CI-TRIAL-00015833EC2075completedPhase 1 / Phase 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)
The purpose of this study is to determine if NIF fluoresent imaging is an effctive approch to detect the margine of the breast tumoral tissue.
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
- Indocyanine green is injected intravenously.
- interventionNames
- Drug: Indocyanine Green
Primary outcomes (1)
- measure
- Study of the evantual difference of indocyanine in mammalian tissue in patients mastocmemezied for breast canrcinoma.
- timeFrame
- 10 months
- description
- Detecting of the fluorescence in between benign and malignant tissue by near infra-red imaging with a camera dictated to identify the margin of the tumor, and Histological detection of indocyanine green distribution in tumor bearing breasts and in axillary pieces of dissection and the detection of tumor cells in lymphe nodes.
Secondary outcomes (1)
- measure
- Microscopical detection of indocyanine green in breast tissue.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histopathological diagnosis of breast cancer for which a mastectomy with axillary dissection is planned. * Informed Consent signed. Exclusion Criteria: * Diagnosis of breast cancer established by lumpectomy or "macro-biopsy". * Operation after neo-adjuvant chemotherapy, * Age less than 18 years. * For pre-menopausal women, an operation planned for the second phase of their cycle. * Inability to give informed consent. * History of allergy or hypersensitivity to the investigational product, iodine. * Clinical or biological hyperthyroidism. * Known "toxic" thyroid nodules or known autonomous (hyperfunctional) thyroid. * A reported pathological coronary artery disease. * Creatinine \> 1.5 mg / dl. * During the 2 weeks before surgery, being on medications which are known to interfere with the ICG (ie anticonvulsants, heparin and haloperidol). * Pregnancy or breast feeding period.
References
Publications (0)
Data not yet available
No reference posted for this study.