Prospective Study on ICG Lymphoscintigraphy Changes Before and After Radiotherapy in Breast Cancer Patients (ICG_prepostRT)

December 9, 2025 updated by: Inah Kim

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yongkyun Jung, M.D.
  • Phone Number: 82-10-3681-7243
  • Email: andnfn@naver.com

Study Locations

  • South Korea
    • Gyeonggido
      • Hwaseong-si, Gyeonggido, South Korea, 18450
        • Recruiting
        • Dongtan Sacred Heart Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • Female, ≥18 years old Pathologically confirmed stage I-III breast cancer Scheduled to receive postoperative radiotherapy (RT)

Exclusion Criteria:

  • Previous or current lymphedema Prior radiotherapy to the ipsilateral breast or axilla History of neoadjuvant chemotherapy Severe systemic diseases (heart, renal, hepatic failure) Active infection Pregnancy or lactation Allergy to indocyanine green (ICG) or iodine-based contrast agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lymphatic Function Before and After Radiotherapy Measured by ICG Lymphography
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.
Quantitative and qualitative changes in lymphatic function assessed by indocyanine green (ICG) lymphography before and after radiotherapy (RT). Parameters include uptake pattern, lymphatic contractility, fluorescence intensity, and dermal backflow pattern. These measures reflect radiation-induced lymphatic dysfunction and may serve as early imaging biomarkers for breast-cancer-related lymphedema (BCRL).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Arm Circumference and Limb Volume After Radiotherapy
Time Frame: Baseline (before radiotherapy), 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion
Change in arm circumference and estimated 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).
Baseline (before radiotherapy), 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inah Kim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2025

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

October 18, 2028

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-10-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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