Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas
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: Avastin, Erbitux, Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy.
- Кому может быть актуально
- Состояния в реестре: Barrett's Esophagus Without Dysplasia, Barrett Oesophagitis With Dysplasia, Esophageal Adenocarcinoma. 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
- Нидерланды
- 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
A Phase 2 Intervention Study: Detection of Early Esophageal Neoplastic Lesions by Quantified Fluorescence Molecular Endoscopy Using Oral and Topical Administration of Bevacizumab-800CW and Cetuximab-800CW
Обзор
Previous studies have confirmed the great potential of quantitative fluorescence molecular endoscopy (qFME) when looking at additional lesion detection initially missed by high-definition white light endoscopy (HD-WLE) for surveillance of Barrett's esophagus.
Подробное описание
However, the investigators hypothesized, that additional lesions can potentially be identified by simultaneous use of two targeted tracers because of variable expression of vascular endothelial growth factor A (VEGFA) and epidermal growth factor receptor (EGFR )within oesophageal adenocarcinoma (EAC). Until now, solely intravenous and topical administration of the tracers has been investigated. However, optimization of tracer administration and shortened incubation is necessary for clinical translation and implementation of this new technique from Barrett's esophagus (BE) expert centers to regional non-expert centers. BE surveillance procedures normally takes up to 15 minutes at regional hospitals, of which most of the procedural time is needed to take biopsies according to the Seattle protocol. Introducing qFME into these hospitals would elongate the procedure time with at least 10 - 15 minutes. This would increase healthcare costs and put increased pressure on BE healthcare. Ideally, the gastroenterologist can immediately start with the qFME procedure without any incubation time while maintaining the best target-to-background ratios (TBR) possible. Oral administration by drinking the tracer prior to the procedure would eliminate incubation time and its consequences. Quantified qFME with oral tracer administration and targeted biopsies could potentially replace the time-consuming, high miss rate Seattle protocol, improve lesion detection and decrease global healthcare costs associated with BE.
Вмешательства
- Препарат Avastin
Orally administered - Препарат Erbitux
Orally administered - Устройство Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy
Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope
Первичные конечные точки
- Feasibility of shortening qFME procedural time by oral administration of bevacizumab-800CW and cetuximab-800CW for the detection of BE neoplasia. [Срок оценки: 12 months]
- Evaluate if the combination of tracers improves lesion detection by the number of invisible lesions detected [Срок оценки: 12 months]
Вторичные конечные точки (5)
- Collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW. [Срок оценки: Five minutes before and ten minutes after tracer administration]
- Heart rate [Срок оценки: Five minutes before and ten minutes after tracer administration]
- Temperature [Срок оценки: Five minutes before and ten minutes after tracer administration]
- To (semi)quantify and evaluate the in vivo fluorescent signal of bevacizumab-800CW and cetuximab-800CW [Срок оценки: 12 months]
- Eventually further specify and objectify the improvement of qFME by standardisation [Срок оценки: 12 months]
Критерии участия
Критерии включения
- BE patients without dysplasia and with suspected/diagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial EAC and planned diagnostic and/or therapeutic endoscopy
- Written informed consent is obtained
Критерии исключения
- Patients under the age of eighteen.
- Submucosal and invasive EAC, also defined as EAC with tumor, node and metastasis (TNM)-classification other than T1.
- Previous radiation therapy for esophageal cancer
- Known immunoglobulin allergy
- Previous chemotherapy, immunotherapy or related surgery
- Prior bevacizumab or cetuximab treatment
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Pregnancy or breast feeding.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Нидерланды · 1 центр
- University Medical Center Groningen — Groningen
Идентификаторы
NCT: NCT05745857 · 16054