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Идёт набор NCT05781555

Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors

Без фазы С лечением Malignant Tumor

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: Experimental: DaRT seeds.
Кому может быть актуально
Состояния в реестре: Malignant Tumor. 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
Израиль
Следующий шаг
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Официальное название

A Prospective, Open Label, One Arm Study for a Compassionate Use of Diffusing Alpha Radiation Therapy

Обзор

This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.

Подробное описание

This is an Open label, one arm, prospective study for Compassionate use for the treatment of malignant tumors. The study objectives are to collect data on the safety and efficacy of DaRT among patients who do not fit the entry of existing investigational trials.

The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.

Вмешательства

  • Устройство Experimental: DaRT seeds
    DaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. The study objectives are to collect data on the general safety and efficacy of DaRT among patients who do not fit the entry criteria of existing investigational trials.

Первичные конечные точки

  • To assess the frequency, severity and causality of acute adverse events. [Срок оценки: From Day 0 (DaRT insertion )]
Вторичные конечные точки (1)
  • To assess the tumor response to DaRT treatment [Срок оценки: 3 months after DaRT seed insertion]

Критерии участия

Критерии включения

  • Subjects with any malignancy
  • Subjects with a tumor size ≤ 7 centimeters in the longest diameter
  • Subjects over 18 years old
  • Subjects' life expectancy is more than 6 months
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after treatment.
  • Subjects/Surrogate decision maker are willing to sign an informed consent form

Критерии исключения

  • Known hypersensitivity to any of the components of the treatment.
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  • Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
  • Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
  • Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
  • High probability of protocol non-compliance (in opinion of investigator).
  • Subjects/Surrogate decision maker not willing to sign an informed consent.
  • Women who are pregnant or breastfeeding.

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
Лечение

Центры проведения

Израиль · 1 центр
  • Hadassah Ein Kerem — Jerusalem

Идентификаторы

NCT: NCT05781555 · CTP- ALL-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗