Идёт набор NCT06667726

An Investigational Scan (18F-DOPA PET/CT) for Improving the Clinical Management of Brain Tumors

Фаза II С лечением Malignant Brain Neoplasm

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: Computed Tomography, Fluorodopa F 18, Positron Emission Tomography.
Кому может быть актуально: Состояния в реестре: Malignant Brain Neoplasm. 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: США
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 Centralized Protocol Evaluating the Safety and Clinical Impact of Amino Acid Pet for Brain Tumors

Обзор

This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.

Подробное описание

PRIMARY OBJECTIVE:

I. To determine whether the addition of amino acid PET to standard of care imaging impacts clinical management of brain tumor patients in over 50% of cases.

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of amino acid PET for brain tumor patients in response to Food and Drug Administration (FDA) guidance that such data is needed to support a potential New Drug Application (NDA) for fluorodopa F 18 (18F-DOPA).

II. To assess the rate of identification of tumor outside of standard magnetic resonance imaging (MRI) imaging.

OUTLINE:

Patients receive 18F-DOPA intravenously (IV) and undergo PET/CT over 30 minutes on day 1.

After completion of study intervention, patients are followed for 3 days.

Вмешательства

Процедура Computed Tomography
Undergo PET/CT
Препарат Fluorodopa F 18
Given IV
Процедура Positron Emission Tomography
Undergo PET/CT

Первичные конечные точки

Impact of 18F-DOPA PET/CT on clinical management [Срок оценки: 3 days post-PET scan, up to 64 days]

Вторичные конечные точки (2)

Incidence of adverse events [Срок оценки: 3 days post-PET scan, up to 64 days]
Rate of identification of tumor outside of standard magnetic resonance imaging (MRI) [Срок оценки: 3 days post-PET scan, up to 64 days]

Критерии участия

Критерии включения

Age 18 and older
Diagnosis of a brain tumor
Indication for amino acid PET imaging, including presurgical evaluation, radiation planning, MR imaging indeterminate for progression versus treatment effect, or clinical need for enhanced monitoring
Ability to give appropriate consent or have an appropriate representative available to do so