Идёт набор NCT06647901

Efficacy of ICG-based NIR Imaging in Intralesional Curettage of Giant Cell Tumors of Bone in Limbs: a Prospective, Single-center, Single-arm, Open Study

Фаза I / Фаза II С лечением Giant Cell Tumor of Bone

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: ICG (Indocyanine Green).
Кому может быть актуально: Состояния в реестре: Giant Cell Tumor of Bone. Базовые параметры: 18 лет — 65 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

ICG fluorescence imaging will be applied during the intralesional curettage of giant cell tumor of bone in the limbs. This study aims to preliminarily explore whether ICG fluorescent-guided curettage could find small residual tumors and reduce the recurrence rate of tumor.

Подробное описание

Recurrence is a problem in the treatment of giant cell tumor of bone(GCTB). With the application of high-speed burr and other adjuvant therapy (phenol, liquid nitrogen freezing, cauterization, etc.), the recurrence rate is greatly reduced, but it is still as high as 20%. The main cause of local recurrence is the difficulty in distinguishing small residual tumor lesions by the naked eye. The application of frozen section is limited due to the long-term decalcification of bone specimens.

Intraoperative near-infrared (NIR) imaging is a promising technology expected to solve the above problems. It allows for real-time scanning of a wide area with tumor showing fluorescence. Such intraoperative fluorescent signals provide objective evidence for the surgeon and are more reliable than subjective visual and tactile information.

This study aims to explore whether ICG-based NIR imaging guided curettage could find small residual tumors and reduce the recurrence rate of GCT.

Вмешательства

Препарат ICG (Indocyanine Green)
Patients will be receive intravenously administrated at a dose of 2 mg/kg on the day before surgery. The drug was dissolved into 250 mL of normal saline and administered using a light-proof infusion apparatus. The time course of administration was 60 min. NIR imaging will be performed during surgery to help identify small tumor residuals.

Первичные конечные точки

local recurrence rate of tumor [Срок оценки: From surgery to 2 years after surgery]

Вторичные конечные точки (2)

Accuracy of ICG prediction tumor residuals [Срок оценки: From surgery to 2 weeks after surgery]
Correlation between fluorescence intensity and pathology findings of tumor residuals [Срок оценки: From surgery to 2 weeks after surgery]

Критерии участия

Критерии включения

. Aged 18-65.
Biopsy confirmed giant cell tumor of bone.
The lesions located in the limbs.
This operation is the initial treatment.
Denosumab and diphosphonates are not used before surgery.
Planned operation is intralesional curettage and filling bone defects with bone cement.
Preoperative bone scan and thin layer (layer thickness ≤3.5mm) chest CT plain scan confirmed that the lesion is a single occurrence without metastasis.
Subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent.