ICG Lymphography Changes Before and After Radiotherapy in Breast Cancer Patients (ICG_prepostRT)
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:
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.
연구 개요
상태
상태
정황
정황
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Inah Kim, M.D.,Ph.D
- 전화번호: 82-10-2937-6852
- 이메일: inahsylvia@gmail.com
연구 연락처 백업
- 이름: Yongkyun Jung, M.D.
- 전화번호: 82-10-3681-7243
- 이메일: andnfn@naver.com
연구 장소
-
-
Gyeonggido
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Hwaseong-si, Gyeonggido, 대한민국, 18450
- 모병
- Dongtan Sacred Heart Hospital
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연락하다:
- Inah Kim, M.D.,Ph.D
- 전화번호: 82-10-2937-6852
- 이메일: inahsylvia@gmail.com
-
연락하다:
- Yongkyun Jung, M.D.
- 전화번호: 82-10-3681-7243
- 이메일: andnfn@naver.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
- Severe systemic diseases (heart, renal, hepatic failure)
- Active infection
- Pregnancy or lactation
- Allergy to indocyanine green (ICG) or iodine-based contrast agents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Lymphatic Function Before and After Radiotherapy Measured by ICG Lymphography
기간: 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). |
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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in other breast ICG findings, Arm Circumference and Limb Volume After Radiotherapy
기간: Baseline (before radiotherapy), within 14days after radiotherapy completion, 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion
|
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). |
Baseline (before radiotherapy), within 14days after radiotherapy completion, 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2025-10-008
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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