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

NCT ID: NCT06672224

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-14
• Study Completion Date: 2026-08-14

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.

Detailed Description

PRIMARY OBJECTIVE:

I. Assess the change in lymphatic architecture resulting from placement of an IV line and fluid administration in patients at risk for BCRL.

SECONDARY OBJECTIVES:

I. Identify changes in presence/severity of lymphedema based on:

Ia. SOZO Digital Health Platform scale; Ib. Patient self-reported outcomes; Ic. Arm circumference. II. Assess association between SOZO scale, MD Anderson Cancer Center (MDACC) lymphedema score (LS), and patient-reported outcomes.

EXPLORATORY OBJECTIVES:

I. Observe changes in mapping of superficial lymphatics that are responsible for the upper extremity arm with use of ICG dye and SPY angiography.

II. Identify risk factors associated with higher rates of lymphedema after IV line/fluid administration.

OUTLINE:

Patients receive ICG dye subcutaneously (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.

Conditions

Breast Cancer-Related Lymphedema; Breast Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Fluid Therapy

Intervention Type: PROCEDURE

Given IV

Indocyanine Green

Intervention Type: DRUG

Given subcutaneously

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Research or Clinical Assessment Tool

Intervention Type: OTHER

Undergo lymphedema assessment

SPY Elite Fluorescence Imaging

Intervention Type: PROCEDURE

Undergo SPY imaging

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Fluid Therapy

Given IV

Intervention Type: PROCEDURE

Indocyanine Green

Given subcutaneously

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Research or Clinical Assessment Tool

Undergo lymphedema assessment

Intervention Type: OTHER

SPY Elite Fluorescence Imaging

Undergo SPY imaging

Intervention Type: PROCEDURE

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

ICG; Clinical Assessment Tool; Clinical or Research Assessment Tool; SPY Elite; SPY Elite Imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Chang

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Other Identifiers

NCI-2024-08855

Identifier Type: REGISTRY

Identifier Source: secondary_id

23823

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23823

Identifier Type: -

Identifier Source: org_study_id