Breast NeoplasmsICG_prepostRTNCT07297927
ICG Lymphography Changes Before and After Radiotherapy in Breast Cancer Patients
An observational study of Breast Neoplasms and Lymphedema Due to Radiation, run by Inah Kim at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Lymphedema Due to Radiation
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Nov 2025to 18 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Female, ≥18 years old
- Pathologically confirmed stage I-III breast cancer
- Scheduled to receive postoperative radiotherapy (RT)
Who cannot join
- Previous or current lymphedema
- Prior radiotherapy to the ipsilateral breast or axilla
- Severe systemic diseases (heart, renal, hepatic failure)
- Active infection
- Pregnancy or lactation
- Allergy to indocyanine green (ICG) or iodine-based contrast agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggido, 18450
Inah Kim, M.D.,Ph.D, 82-10-2937-6852, inahsylvia@gmail.com
Yongkyun Jung, M.D., 82-10-3681-7243, andnfn@naver.com
About this study
Official title: Prospective Study on ICG Lymphography Changes Before and After Radiotherapy in Breast Cancer Patients
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:
Read more
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.
- Conditions
- Breast Neoplasms, Lymphedema Due to Radiation
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline (before radiotherapy), within 14days after radiotherapy completion, 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start5 Nov 2025
- Primary completion2 Apr 2027 (estimated)
- Study completion18 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inah Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inah Kim, Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297927
- Sponsor's protocol ID
- 2025-10-008
- Acronym
- ICG_prepostRT
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on ICG Lymphography Changes Before and After Radiotherapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07297927
- Acronym / sponsor ID
- ICG_prepostRT / 2025-10-008
- Conditions
- Breast Neoplasms, Lymphedema Due to Radiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Inah KimUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 2 Apr 2027 (estimated)
- Study completion
- 18 Oct 2028 (estimated)
- First posted
- 22 Dec 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Female, ≥18 years old
- Pathologically confirmed stage I-III breast cancer
- Scheduled to receive postoperative radiotherapy (RT)
Key exclusion criteria (6 listed)
- Previous or current lymphedema
- Prior radiotherapy to the ipsilateral breast or axilla
- Severe systemic diseases (heart, renal, hepatic failure)
- Active infection
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
1 secondary outcome
Change in other breast ICG findings, Arm Circumference and Limb Volume After Radiotherapy
Time frame: Baseline (before radiotherapy), within 14days after radiotherapy completion, 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Lymphedema Due to Radiation, run by Inah Kim at 1 site in South Korea.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inah Kim, M.D.,Ph.D (82-10-2937-6852, inahsylvia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 28 Sep 2026.