Post-market Safety Study of LUMISIGHT
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Hypersensitivity Reactions. 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Post-market Evaluation of Incidence Rate of Anaphylaxis and Hypersensitivity Reactions Associated With LUMISIGHT Administration
Обзор
This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery. Participants are indicated to receive LUMISIGHT as part of their breast cancer care. There is no investigational drug associated with this study. LUMISIGHT has a risk of serious hypersensitivity reaction, and this study seeks to further evaluate that risk.
Подробное описание
The LumiSystem is the combination of FDA approved LUMISIGHT (pegulicianine) for injection (NDA 214511) and Lumicell Direct Visualization System (DVS) (PMA P230014). These products are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. This post market study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with breast cancer undergoing lumpectomy surgery. Additional study objectives are to evaluate the incidence of and characterize other severe hypersensitivity reactions. Study assessments include assessment of adverse events of interest (including laboratory data as indicated in this protocol), physical examination, and assessment of blood pressure, heart rate, and oxygen saturation before and after LUMISIGHT administration. Suspected cases of anaphylaxis and hypersensitivity reactions are adjudicated by a Clinical Endpoint Adjudication Committee according to a standard anaphylaxis definition and hypersensitivity grading system.
Первичные конечные точки
- Incidence of adjudicated anaphylaxis [Срок оценки: 75 +/- 15 minutes post LUMISIGHT injection]
Вторичные конечные точки (5)
- Incidence of adjudicated serious hypersensitivity reactions [Срок оценки: 75 +/- 15 minutes post LUMISIGHT injection]
- Incidence of hypersensitivity reactions [Срок оценки: 75 +/- 15 minutes post LUMISIGHT injection]
- Distribution of severity of adjudicated hypersensitivity reactions [Срок оценки: 75 +/- 15 minutes post LUMISIGHT injection]
- Descriptive statistics of population with occurrence of adjudicated anaphylaxis. [Срок оценки: 75 +/- 15 minutes of LUMISIGHT injection]
- Descriptive statistics of population with occurrence of adjudicated severe hypersensitivity reactions. [Срок оценки: 75 +/- 15 minutes post LUMISIGHT injection]
Критерии участия
Критерии включения
- 18 years of age or older
- Has been diagnosed with primary breast cancer and scheduled to undergo a lumpectomy procedure
- Indicated to receive LUMISIGHT at a dose of 1 mg/kg
- Willing and able to comply with the study procedures
Критерии исключения
- History of hypersensitivity reactions to pegulicianine.
- Inability to comply with the requirements of the protocol.
- Treating physician does not think it is in the best interest of the patient to participate.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Smith BL, Hunt KK, Carr D, Blumencranz PW, Hwang ES, Gadd MA, Stone K, Dyess DL, Dodge D, Valente S, Dekhne N, Clark P, Lee MC, Samiian L, Lesnikoski BA, Clark L, Smith KP, Chang M, Harris DK, Schlossberg B, Ferrer J, Wapnir IL. Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery. NEJM Evid. 2023 Jul;2(7):EVIDoa2200333. doi: 10.1056/EVIDoa2200333. Epub 2023 Apr 27. PMID 38320161
Идентификаторы
NCT: NCT07572162 · CLP00203