Clinical trial · Interventional
Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer
NCT01771666CI-TRIAL-00030751completedPhase 2Results postedClinicalTrials.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 Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99technetium-sulfur colloid radiolabel | Drug | — | UNRESOLVED |
| Indocyanine Green | Drug | — | UNRESOLVED |
| Isosulfan blue | Drug | — | UNRESOLVED |
| SPY Elite Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ISB and ICG
- description
- The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started. (IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity.
- interventionNames
- Device: SPY Elite Imaging
- Drug: Indocyanine Green
- Drug: Isosulfan blue
- Drug: 99technetium-sulfur colloid radiolabel
Primary outcomes (1)
- measure
- Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)
- timeFrame
- 1 day
- description
- Number of women with agreement of the two dies \[ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)\] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Signed written informed consent. * Women undergoing sentinel lymph node biopsy. * Women with breast cancer with known or suspected lymph node involvement. * Women undergoing sentinel node identification and completion axillary lymph node dissection. * Women of 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2. * Complete Blood Count (CBC) and basic Metabolic Panel within 6 months Exclusion Criteria: * History of liver or kidney failure will not be eligible. * Allergies to iodine containing products will not be eligible. * Women who are pregnant will not be eligible. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.