Идёт набор NCT04197297

Brain Imaging Biomarkers in Patients With Brain Metastasis

Фаза II С лечением Brain Metastases, Adult

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: CT and MRI Scans.
Кому может быть актуально: Состояния в реестре: Brain Metastases, Adult. 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: Канада
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

Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy

Обзор

A biomarker is a measurable indicator of the severity or presence of some disease state. In this study, brain metastases patients who will be receiving radiation treatment, will undergo CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans prior to and after radiation treatment to measure these biomarkers. This is a single-center phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.

Подробное описание

Advances in medical imaging can provide useful information to guide and look at the response to treatment. Previous studies suggest early changes in the tumor after radiation treatment may be detectable using special MRI (Magnetic Resonance Imaging), and CT (Computed Tomography) scans. A biomarker is a measureable indicator of the severity or presence of some disease state. Previous studies suggest that the change in several imaging biomarkers can predict who will respond to radiation treatment. In this study, patients will undergo CT and MRI scans prior to and after radiation treatment to measure these biomarkers. The purpose of this study is to validate the predictive abilities of biomarkers in terms of determining how patients will respond to radiation treatment. This is a single-center phase II study, which will be conducted at the Princess Margaret Cancer Center. The study will be enrolling up to a total of 90 patients who will be receiving radiation treatment for brain metastases. Patients will be asked to participate within this study for 2 years.

Вмешательства

Диагностический тест CT and MRI Scans
CT and MRI scans will occur before and after radiation therapy.

Первичные конечные точки

Response Assessment in Neuro-Oncology (RANO) to validate biomarkers [Срок оценки: Up to 2 years.]
Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers [Срок оценки: Up to 2 years.]
Progression Free Survival (PFS) to validate biomarkers [Срок оценки: Up to 2 years.]

Вторичные конечные точки (6)

Objective (Radiological) Progression [Срок оценки: Up to 2 years.]
Objective (Radiological) Response [Срок оценки: Up to 2 years.]
Time to Intracranial Local Progression [Срок оценки: Up to 2 years.]
Time to Intracranial Distant Progression [Срок оценки: Up to 2 years.]
Brain Progression Free Survival [Срок оценки: Up to 2 years.]
Unexpected and/or Serious Toxicities (AEs) [Срок оценки: Up to 2 years.]

Критерии участия

Критерии включения

Biopsy proven primary malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
At least one index lesion with diameter > 1cm and without imaging evidence of hemorrhage
Patients age > 18 years of age
Patients planned for RT to brain metastases
Ability to understand and the willingness to sign a written informed consent document.