UHFUS Characterization of Normal Lymphatic Anatomy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Indocyanine green (ICG) solution injection, Ultra-High Frequency Ultrasound.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Redefining the Normal: Ultra-High Frequency Ultrasound Characterization of Lymphatic Anatomy in Patients With Breast Cancer
Обзор
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer.
Подробное описание
This is a prospective pilot study of breast cancer patients undergoing axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB). Participants will undergo ultra-high frequency ultrasound (UHFUS) imaging with indocyanine green (ICG) dye to map lymphatic channels between the wrist and elbow to investigate normal lymphatic anatomy in patients with breast cancer. Additionally, the study will evaluate the adverse reactions to indocyanine green (ICG) dye, characterize variability in ultrasonographic characteristics of lymphatic channels, investigate the correlation of indocyanine green (ICG) pathways and UHFUS characteristics of lymphatic channels, and investigate the correlation of ICG lymphography patterns and patient demographics.
The primary study objective is to investigate normal lymphatic anatomy in patients with breast cancer using UHFUS. We hypothesize that normal lymphatic anatomy exhibits consistent ultrasonographic characteristics, and ICG lymphography can reliably correlate with UHFUS findings.
Вмешательства
- Процедура Indocyanine green (ICG) solution injection
0.1cc of 2.5 mg/cc Indocyanine green (ICG) solution will be injected intradermally at the 1st and 4th webspaces of the hand, and radial and ulnar volar wrist areas. - Устройство Ultra-High Frequency Ultrasound
UHFUS will capture still images at specific landmarks along the wrist-to-elbow axis to characterize lymphatic channels. The following quantitative data of lymphatic channels will be captured: 1\. Outer diameter (i.e., total diameter including wall and lumen); 2. Inner diameter (i.e., diameter of the lumen only); and 3. Wall thickness (i.e., the thickness of the lymphatic channel wall)
Первичные конечные точки
- Outer lymphatic vessel diameter [Срок оценки: During ultra-high frequency ultrasound imaging]
Вторичные конечные точки (11)
- Vessel wall thickness [Срок оценки: During ultra-high frequency ultrasound imaging]
- Degree of sclerosis [Срок оценки: During ultra-high frequency ultrasound imaging]
- Number of lymphatic channels [Срок оценки: During ultra-high frequency ultrasound imaging]
- Channel confluence points [Срок оценки: During ultra-high frequency ultrasound imaging]
- Incidence of allergic or anaphylactic reactions, including rash, pruritus, hypotension, or respiratory distress. [Срок оценки: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.]
- Incidence of injection site reactions [Срок оценки: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.]
- Duration of injection site reactions [Срок оценки: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.]
- Required interventions (e.g., antibiotics) for injection site reactions [Срок оценки: From the time of indocyanine green (ICG) dye injection up to 12 hours of hospital discharge.]
- Quantification of the lymphatic channels identified/ visualized along linear ICG patterns [Срок оценки: During ultra-high frequency ultrasound imaging]
- Identification of anatomical locations where lymphatic channels merge or narrow (i.e., channel confluence and constriction) [Срок оценки: During ultra-high frequency ultrasound imaging]
- correlation of ICG lymphography patterns and patient demographics [Срок оценки: During ultra-high frequency ultrasound imaging]
Критерии участия
Критерии включения
- 1\. Aged 18+ at the time of consent.
- 2\. Confirmed breast cancer diagnosis
- 3\. Planned ALND (CPT code: 38745) or SLNB (CPT code: 38900) for breast cancer treatment
- 4\. Provision of a signed and dated informed consent form.
- 5\. Stated willingness to comply with all study procedures and availability for the duration of the study.
Критерии исключения
- 1\. History of transient or permanent edema of the extremity, including edema ≥stage 1 per the International Society of Lymphology (ISL) staging system 15
- 2\. History of prior axillary nodal surgery
- 3\. History of any lymphatic disease or venous disease of the upper extremity, including deep venous thrombosis
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
США · 1 центр
- University of California Davis Health — Sacramento
Идентификаторы
NCT: NCT07677839 · 2287319-1