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Набор по приглашению NCT07380867

Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery.

Без фазы С лечением Colorectal Cancer Endoscopic Tattoo of Suspected Colon Cancer Indocyanine Green (ICG)

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: LuminoMark inj. 0.2mL.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Endoscopic Tattoo of Suspected Colon Cancer, Indocyanine Green (ICG). Базовые параметры: 19 лет — 80 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
South Korea
Следующий шаг
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Официальное название

Localization of Preoperative Endoscopic Tattooing Using Indocyanine Green(ICG)-Hyaluronic Acid Mixture (Luminomark) for Colorectal Cancer Surgery

Обзор

Early-stage lesions are difficult to identify intraoperatively during colorectal cancer surgery. Therefore, preoperative lesion marking using a colonoscopic approach is crucial to confirm the location and extent of resection during surgery. Preoperative lesion location can help determine the optimal extent of resection, thereby increasing the accuracy of colorectal surgery. This is particularly true for cases requiring surgery after early-stage colorectal cancer or endoscopic tumor resection. Therefore, preoperative marking with indocyanine green (IDG) allows for laparoscopic identification of the lesion. This is crucial because it allows for precise lesion location, thereby enhancing surgical accuracy and preventing the need for unnecessary additional resections.

Подробное описание

The recently developed indocyanine green (ICG)-hyaluronic acid mixture (LuminoMark™, Hanlim Pharm Co., Seoul, Republic of Korea) is a surgical marker combining indocyanine green with macroaggregated albumin (MAA). Its non-diffusing properties allow for precise lesion targeting. It addresses unmet needs of existing surgical markers, such as skin pigmentation and surgical site contamination. It effectively adsorbs onto cancerous lesions, enabling precise lesion location. Real-time tracking of the pigment allows for clear identification of the lesion's extent of removal, enhancing convenience and usability during surgery. It has already demonstrated superiority over existing labeling methods in a phase 3 clinical trial for breast lesions, receiving approval from the Ministry of Food and Drug Safety. Clinical trials are underway for various cancer types, including gastric and colon cancer, but it remains an over-approved drug.

Therefore, this study aimed to determine the accuracy of endoscopic labeling using a novel luminomarker for preoperative colon cancer lesion marking.

Вмешательства

  • Препарат LuminoMark inj. 0.2mL
    * Endoscopic tattooing with Luminomark on submucosal layer of bowel * Location of injection : total 4 sites 1. Left lateral side of the tumor 2. Right lateral side of the tumor 3. opposite side of the tumor 4. distal side of the tumor * Dosage of injection: -at least 0.5cc per a site, total 2ml

Первичные конечные точки

  • Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing [Срок оценки: Perioperative/Periprocedural]
Вторичные конечные точки (1)
  • post-procedure related complication [Срок оценки: through postoperative 4 days]

Критерии участия

Критерии включения

  • Adult patients aged 19-80 years
  • Clinical T1-2, N0, without distant metastasis on imaging
  • If surgical treatment is required after ESD (endoscopic mucosal resection)\*
  • If endoscopic lesion marking is required as determined by the attending physician

Критерии исключения

  • Patients diagnosed with distant metastases (M1)
  • Severe hepatic or renal dysfunction (Child-Pugh Class C, eGFR <39 mL/min/1.73 m2)
  • Pregnant or lactating women
  • High risk of intestinal obstruction or perforation
  • Patients deemed inappropriate by the investigator (high-risk patients, such as patients with lung or heart disease, risk factors for bleeding, hepatitis virus infection, or other cancers)
  • Patients with a history of hypersensitivity to the luminomarker drug or its components
  • Patients who have experienced skin hypersensitivity to the dye
  • Patients who do not wish to participate in the study

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

South Korea · 1 центр
  • Seoul St.Mary's hospital, the Catholic university of Korea — Seoul

Идентификаторы

NCT: NCT07380867 · KC25MASI0456

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗