ICG Lymphography Changes Before and After Radiotherapy in Breast Cancer Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInah Kim

About this trial

The goal of this observational study is to learn how the lymphatic system changes before and after radiotherapy in female patients with breast cancer. The study aims to understand early lymphatic changes that may lead to breast-cancer-related lymphedema (BCRL) and to help identify patients who might benefit from early preventive rehabilitation.

The main questions it aims to answer are:

How does lymphatic flow and vessel function change after radiotherapy, as measured by indocyanine green (ICG) lymphography?

Can early imaging changes on ICG lymphography predict later swelling or lymphedema symptoms in the arm?

There is no comparison or treatment group, since all participants will receive radiotherapy as part of their standard breast cancer care.

Participants will:

Undergo ICG lymphography before radiotherapy and again within 4-6 weeks after completing radiotherapy

Receive a small injection of ICG dye under the skin and have near-infrared imaging to visualize lymphatic flow

Complete follow-up assessments (for some participants) at 3, 6, or 12 months to monitor long-term lymphatic changes

Continue their usual standard medical and rehabilitation care throughout the study

This study will include 40 female participants, aged 18 years or older, who have been diagnosed with stage I-III breast cancer and are scheduled for postoperative radiotherapy. Participants with a history of lymphedema, prior radiotherapy, severe organ disease, or known ICG/iodine allergy will not be included.

The information collected will include imaging findings from ICG lymphography, arm circumference and volume measurements, and patient-reported outcomes on arm discomfort or swelling. These data will help researchers identify early imaging biomarkers of radiation-induced lymphatic dysfunction.

The study does not involve any experimental treatment or random assignment. All procedures are routine diagnostic or rehabilitation methods that are already approved for clinical use. The ICG test uses a very small amount of dye and is considered safe, with allergic reactions being rare.

The findings of this study may provide new insights into how radiotherapy affects the lymphatic system and may contribute to developing personalized strategies to prevent or minimize lymphedema after breast cancer treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, ≥18 years old

Pathologically confirmed stage I-III breast cancer

Scheduled to receive postoperative radiotherapy (RT)

Disqualifiers

Previous or current lymphedema

Prior radiotherapy to the ipsilateral breast or axilla

Severe systemic diseases (heart, renal, hepatic failure)

Active infection

Trial population

Female breast cancer survivors (stage I-III) scheduled for adjuvant radiotherapy after surgery. Participants are recruited consecutively from the Department of Rehabilitation Medicine, Radiation Oncology and General Surgery at Hallym University Dongtan Sacred Heart Hospital. The study population represents patients at risk for radiation-induced lymphatic dysfunction or breast-cancer-related lymphedema.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Change in Lymphatic Function Before and After Radiotherapy Measured by ICG Lymphography

Changes in lymphatic function assessed by indocyanine green (ICG) lymphography before and after radiotherapy (RT) including paired T0-to-T1 change in breast indocyanine green (ICG) stage. This reflect radiation-induced lymphatic dysfunction and may serve as early imaging biomarkers for breast-cancer-related lymphedema (BCRL).

Time frame
Baseline (before radiotherapy), 4-6 weeks after completion of radiotherapy, and optionally at 3, 6, and 12 months after RT completion if follow-up imaging is performed.

Secondary outcomes

1

Change in other breast ICG findings, Arm Circumference and Limb Volume After Radiotherapy

Change in limb volume (using the truncated cone formula) before and after radiotherapy (RT), compared with baseline measurements. These measurements will be used to determine whether early lymphatic imaging changes are correlated with the development or progression of breast-cancer-related lymphedema (BCRL).

Time frame
Baseline (before radiotherapy), within 14days after radiotherapy completion, 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inah Kim

Lead sponsor

Dongtan Sacred Heart Hospital

Sponsor institution