Serial Advanced Magnetic Resonance Imaging Scan for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma
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: Magnetic Resonance Imaging, Neurocognitive Assessment, Quality-of-Life Assessment, Questionnaire Administration.
- Кому может быть актуально
- Состояния в реестре: Malignant Glioma. 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
Serial Advanced Magnetic Resonance Imaging (MRI) for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma
Обзор
This study examines whether repeated magnetic resonance imaging (MRI)s scan helps identify changes in the tumor during radiation and chemotherapy treatment in patients with high grade glioma. Additional MRIs scan may help researchers to see changes in the status of the disease. Seeing these changes may result in changes to the treatment plan.
Подробное описание
PRIMARY OBJECTIVES:
I. To compare the radiation dosimetric coverage of the surgical cavity and any residual tumor when the immediate post-operative MRI is used versus (vs.) newly acquired MRI prior to radiation therapy.
II. To evaluate the cumulative dosimetric differences for the target volume and normal structures between an adaptive radiotherapy approach based on serial MRI vs. the conventionally delivered radiotherapy plan using the target and normal structure volumes from the initial MRI simulation.
SECONDARY OBJECTIVES:
I. To report the incidence of tumor progression between surgery and radiation therapy and factors related to higher risk of tumor progression (e.g. Time interval between surgery and radiation, extent of surgery, molecular characteristics).
II. To evaluate the relationship between the delivered dosimetry and patterns of failure and changes in neurocognitive function.
III. To evaluate the relationship between voxel-wise quantitative changes on multiparametric MRI including apparent diffusion coefficient (ADC), fractional anisotropy (FA), relative cerebral blood volume (rCBV), fractional volume of the extravascular, extracellular space (ve) and Ktrans (transfer constant that characterizes the diffusive transport of low-molecular weight gadolinium across the capillary endothelium) with patterns of failure and changes in neurocognitive function.
IV. To determine if early post-operative progression is associated with worse overall survival.
V. To determine the difference in reported pseudoprogression at first follow-up after completing radiation when the baseline MRI is the immediate post-op MRI vs. newly acquired MRI prior to radiation therapy.
VI. To compare image co-registration accuracy between the radiation planning computed tomography (CT) images and MRI for the immediate post-op MRI vs. newly acquired MRI prior to radiation therapy.
VII. To evaluate the relationship between standard clinical neurocognitive function (NCF) and iPad based NCF (iNCF) test results.
OUTLINE:
Patients undergo MRI with and without contrast immediately before radiotherapy (for radiation planning) and at mid treatment (week 3). Patients also undergo MRI without contrast on weeks 1, 2, 4, 5, and 6 of radiotherapy. Patients may also undergo neurocognitive function testing over 70 minutes before treatment, at the end of each week of treatment, and at 3 and 6 months after completion of treatment.
Вмешательства
- Процедура Magnetic Resonance Imaging
Undergo MRI - Другое Neurocognitive Assessment
Undergo neurocognitive testing - Другое Quality-of-Life Assessment
Ancillary studies - Другое Questionnaire Administration
Ancillary studies
Первичные конечные точки
- Differences in the delineated target and organ at risk volumes and dosimetry [Срок оценки: Up to 2 years]
- Cumulative dosimetric differences for the target volume and normal structures [Срок оценки: Up to 2 years]
Вторичные конечные точки (7)
- Incidence and temporal relationship of tumor progression between surgery and radiation therapy [Срок оценки: Up to 2 years]
- Local tumor control [Срок оценки: At 6 months post-treatment]
- Local tumor control [Срок оценки: At 12 months post-treatment]
- Overall survival (OS) [Срок оценки: From the date of start of radiation to the date of death, assessed up to 2 years]
- Changes in co-registration accuracy under the two settings [Срок оценки: Baseline up to 2 years]
- Difference in reported pseudoprogression [Срок оценки: Up to 6 weeks after completion of radiation]
- Dosimetric differences [Срок оценки: Up to 2 years]
Критерии участия
Критерии включения
- All patients with histologic confirmation of high grade glioma
- Patients must be age >= 18 years
- Patients must sign informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol, and has been approved and amended by the MD Anderson Cancer Center (MDACC) Institutional Review Board (IRB)
- Patients must have Karnofsky performance status (KPS) >= 60
- Patients must be able to obtain an MRI scan with gadolinium contrast
- Female patients of childbearing age must not be pregnant as determined with a serum beta human chorionic gonadotropin (HCG) no greater than 14 days prior to study registration, or breastfeeding. (The exclusion is made because gadolinium may be teratogenic in pregnancy). Female patients who consent to participate in the study will need to use contraceptive methods for the duration of the study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- M D Anderson Cancer Center — Houston
Идентификаторы
NCT: NCT04771806 · PA17-0844 · NCI-2020-08129 · PA17-0844