Clinical trial NCT06672224: Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema
Official title: Prospective Analysis of Patients at Risk for Breast Cancer-Related Lymphedema (BCRL) Using Indocyanine Green (ICG) Fluoroscopy and SPYTM Angiography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer-Related Lymphedema
Breast Carcinoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of patients with worsening lymphedema in the affected arm
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in lymphedema severity based on SOZO Digital Health Platform scale
timeFrame: Baseline to 12 months
measure: Change in patient self-reported outcomes scores
timeFrame: Baseline to 12 months
measure: Change in arm circumference measurements
timeFrame: Baseline to 12 months
measure: Correlation between lymphedema assessment methods (1) MDACC LS, (2) patient-reported outcomes, (3) SOZO scale, and (4) arm circumference
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jeff Chang
role: PRINCIPAL_INVESTIGATOR
References: