Clinical trial · Interventional
Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema
Prospective Analysis of Patients at Risk for Breast Cancer-Related Lymphedema (BCRL) Using Indocyanine Green (ICG) Fluoroscopy and SPYTM Angiography
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
This clinical trial assesses the change in lymphatic structure from placement of an intravenous (IV) line and fluid administration using a diagnostic agent, indocyanine green (ICG), with SPY (Trademark) angiography in breast cancer patients at risk for breast cancer-related lymphedema (BCRL). Patients that are diagnosed with breast cancer with lymph node involvement often undergo treatment that includes surgery to remove the axillary nodes and radiation. Unfortunately, this procedure increases the incidence of BCRL in the surgical arm, as well as other problems including heaviness of the arm, fibrotic skin changes, and an increase in infection risk. Because of these symptoms, venipuncture (blood draw) is often avoided in these arms. Researchers want to show that placement of an IV line and fluid administration in patients at risk for BCRL will indeed not alter the lymphatic structure of the arm and will not change the incidence of BCRL by administering indocyanine green (ICG) dye to patients and assessing their arm lymphatics. ICG is a fluorescent dye that is able to be visualized by the SPY angiography imaging system as it travels through the lymphatic system, allowing researchers to assess how well blood flows throughout the body. Receiving ICG and undergoing SPY angiography may be effective in showing that placement of an IV and fluid administration in breast cancer patients at risk for BCRL will not alter the lymphatic structure of their arm and will not change the incidence of BCRL.
Conditions
Conditions (2)
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-Related Lymphedema | — | UNRESOLVED | — |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluid Therapy | Procedure | — | UNRESOLVED |
| Indocyanine Green | Drug | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Research or Clinical Assessment Tool | Other | — | UNRESOLVED |
| SPY Elite Fluorescence Imaging | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (ICG, fluid, SPY, lymphedema assessment)
- description
- Patients receive ICG dye SC and receive fluids IV over one hour and undergo SPY imaging and lymphedema assessment on day 1. Patients also receive ICG dye and undergo imaging and lymphedema assessments again at 1, 3, 6, and 12 months on study.
- interventionNames
- Procedure: Fluid Therapy
- Drug: Indocyanine Green
- Other: Questionnaire Administration
- Other: Research or Clinical Assessment Tool
- Procedure: SPY Elite Fluorescence Imaging
- Other: Survey Administration
Primary outcomes (1)
- measure
- Percentage of patients with worsening lymphedema in the affected arm
- timeFrame
- Baseline to 12 months
- description
- Measured by the MD Anderson Cancer Center (MDACC) lymphedema score (LS) (measured on a scale of 0 to 5) increased by at least 1 level. Will be estimated as a percentage of patients with MDACC lymphedema score that is at least 1 unit worse at 12 months than at baseline; 95% confidence interval (CI) will be calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented written informed consent of the participant * Men or women age: \>= 18 years * Diagnosis of breast cancer * Full axillary dissection at least 12 months prior * Patient needs vena puncture and has problem with access in the contralateral arm. Recruitment includes patients who do not wish to use their contralateral arm, lower extremities, or central access through their neck, as well as patients for whom multiple attempts result in increased anxiety, discomfort, and treatment delays * No clinical evidence of lymphedema by MD Anderson grading system and normal SOZO values compared to contralateral arm * Willingness to: * Complete Lymphedema Life Impact Scale (LLIS) survey * Allow measurement of arm circumference, bioimpedance, and ICG imaging in real time * Permit medical record/clinical laboratory result review Exclusion Criteria: * Patients with active malignancy (i.e., currently undergoing treatment), infection, or bleeding tendency * Diagnosis of lymphedema * Women of childbearing potential: pregnant/nursing
References
Publications (0)
Data not yet available