Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema

NCT06672224 | Withdrawn DMC

• 3 other identifiers: 23823NCI-2024-08855P30CA033572
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Breast Cancer-Related Lymphedema; Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with worsening lymphedema in the affected arm

  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.

  Baseline to 12 months

Secondary Outcomes (4)

• Change in lymphedema severity based on SOZO Digital Health Platform scale

  Baseline to 12 months

• Change in patient self-reported outcomes scores

  Baseline to 12 months

• Change in arm circumference measurements

  Baseline to 12 months

• Correlation between lymphedema assessment methods (1) MDACC LS, (2) patient-reported outcomes, (3) SOZO scale, and (4) arm circumference

  Baseline to 12 months

Study Arms (1)

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

EXPERIMENTAL

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.

Procedure: Fluid Therapy; Drug: Indocyanine Green; Other: Questionnaire Administration; Other: Research or Clinical Assessment Tool; Procedure: SPY Elite Fluorescence Imaging; Other: Survey Administration

Interventions

Fluid Therapy PROCEDURE

Given IV

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Indocyanine Green DRUG

Given subcutaneously

Also known as: ICG

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Questionnaire Administration OTHER

Ancillary studies

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Research or Clinical Assessment Tool OTHER

Undergo lymphedema assessment

Also known as: Clinical Assessment Tool, Clinical or Research Assessment Tool

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

SPY Elite Fluorescence Imaging PROCEDURE

Undergo SPY imaging

Also known as: SPY Elite, SPY Elite Imaging

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Survey Administration OTHER

Ancillary studies

Supportive Care (ICG, fluid, SPY, lymphedema assessment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with active malignancy (i.e., currently undergoing treatment), infection, or bleeding tendency
• Diagnosis of lymphedema
• Women of childbearing potential: pregnant/nursing

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms

Interventions

Fluid Therapy; Indocyanine Green

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeff Chang

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: August 14, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09