Breast Cancer-Related LymphedemaNCT06672224
Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema
A study testing Fluid Therapy, Indocyanine Green and Questionnaire Administration in people with Breast Cancer-Related Lymphedema and Breast Carcinoma, run by City of Hope Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer-Related Lymphedema, Breast Carcinoma
- What is being tested?
- Fluid Therapy, Indocyanine Green and Questionnaire Administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Aug 2025to 14 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Patients with active malignancy (i.e., currently undergoing treatment), infection, or bleeding tendency
- Diagnosis of lymphedema
- Women of childbearing potential: pregnant/nursing
About this study
Official title: Prospective Analysis of Patients at Risk for Breast Cancer-Related Lymphedema (BCRL) Using Indocyanine Green (ICG) Fluoroscopy and SPYTM Angiography
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the change in lymphatic architecture resulting from placement of an IV line and fluid administration in patients at risk for BCRL.
SECONDARY OBJECTIVES:
- 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:
- 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
- Being tested
- Fluid Therapy, Indocyanine Green, Questionnaire Administration, Research or Clinical Assessment Tool, SPY Elite Fluorescence Imaging
- Medical subject headings
- Breast Cancer Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid TherapyProcedure or surgery
Given IV
Indocyanine GreenDrug
Also called ICG
Given subcutaneously
Questionnaire AdministrationOther
Ancillary studies
Research or Clinical Assessment ToolOther
Also called Clinical Assessment Tool, Clinical or Research Assessment Tool
Undergo lymphedema assessment
SPY Elite Fluorescence ImagingProcedure or surgery
Also called SPY Elite, SPY Elite Imaging
Undergo SPY imaging
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Fluid Therapy; Drug: Indocyanine Green; Other: Questionnaire Administration; Other: Research or Clinical Assessment Tool; Procedure: SPY Elite Fluorescence Imaging; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (4)
Change in lymphedema severity based on SOZO Digital Health Platform scale
Will be calculated (with appropriate confidence intervals); Pearson (or Spearman, as appropriate) correlation coefficients will be calculated to assess the strength of relationship between all four assessment methods (all time points). Graphical representation of data will be used to help understand and assess the nature of the relationship of these modalities.
Measured: Baseline to 12 months
Change in patient self-reported outcomes scores
Will be calculated (with appropriate confidence intervals); Pearson (or Spearman, as appropriate) correlation coefficients will be calculated to assess the strength of relationship between all four assessment methods (all time points). Graphical representation of data will be used to help understand and assess the nature of the relationship of these modalities.
Measured: Baseline to 12 months
Change in arm circumference measurements
Will be calculated (with appropriate confidence intervals); Pearson (or Spearman, as appropriate) correlation coefficients will be calculated to assess the strength of relationship between all four assessment methods (all time points). Graphical representation of data will be used to help understand and assess the nature of the relationship of these modalities.
Measured: Baseline to 12 months
Correlation between lymphedema assessment methods (1) MDACC LS, (2) patient-reported outcomes, (3) SOZO scale, and (4) arm circumference
Will be calculated (with appropriate confidence intervals); Pearson (or Spearman, as appropriate) correlation coefficients will be calculated to assess the strength of relationship between all four assessment methods (all time points). Graphical representation of data will be used to help understand and assess the nature of the relationship of these modalities.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start14 Aug 2025 (estimated)
- Primary completion14 Aug 2026 (estimated)
- Study completion14 Aug 2026 (estimated)
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer-Related LymphedemaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeff Chang, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672224
- Sponsor's protocol ID
- 23823
- Other IDs
- NCI-2024-08855, 23823, P30CA033572
- Status last verified
- Sep 2025
- First submitted
- 1 Nov 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Patients at Risk for Breast Cancer-Related Lymphedema (BCRL) Using Indocyanine Green (ICG) Fluoroscopy and SPYTM Angiography
- ClinicalTrials.gov ID
- NCT06672224
- Acronym / sponsor ID
- 23823
- Conditions
- Breast Cancer-Related Lymphedema, Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Aug 2025 (estimated)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 14 Aug 2026 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the change in lymphatic architecture resulting from placement of an IV line and fluid administration in patients at risk for BCRL.
SECONDARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (ICG, fluid, SPY, lymphedema assessment) | Experimental | Procedure: Fluid Therapy, Drug: Indocyanine Green, Other: Questionnaire Administration, Other: Research or Clinical Assessment Tool, Procedure: SPY Elite Fluorescence Imaging, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with active malignancy (i.e., currently undergoing treatment), infection, or bleeding tendency
- Diagnosis of lymphedema
- Women of childbearing potential: pregnant/nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid TherapyGiven IV | Procedure or surgery | Supportive Care (ICG, fluid, SPY, lymphedema assessment) |
| Indocyanine GreenAlso: ICGGiven subcutaneously | Drug | Supportive Care (ICG, fluid, SPY, lymphedema assessment) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (ICG, fluid, SPY, lymphedema assessment) |
| Research or Clinical Assessment ToolAlso: Clinical Assessment Tool, Clinical or Research Assessment ToolUndergo lymphedema assessment | Other | Supportive Care (ICG, fluid, SPY, lymphedema assessment) |
| SPY Elite Fluorescence ImagingAlso: SPY Elite, SPY Elite ImagingUndergo SPY imaging | Procedure or surgery | Supportive Care (ICG, fluid, SPY, lymphedema assessment) |
| Survey AdministrationAncillary studies | Other | Supportive Care (ICG, fluid, SPY, lymphedema assessment) |
Primary outcome
Percentage of patients with worsening lymphedema in the affected arm
Time frame: Baseline to 12 months
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.
4 secondary outcomes
Change in lymphedema severity based on SOZO Digital Health Platform scale
Time frame: Baseline to 12 months
Change in patient self-reported outcomes scores
Time frame: Baseline to 12 months
Change in arm circumference measurements
Time frame: Baseline to 12 months
Correlation between lymphedema assessment methods (1) MDACC LS, (2) patient-reported outcomes, (3) SOZO scale, and (4) arm circumference
Time frame: Baseline to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Chang principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Therapy, Indocyanine Green and Questionnaire Administration in people with Breast Cancer-Related Lymphedema and Breast Carcinoma, run by City of Hope Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with worsening lymphedema in the affected arm (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.