MRI in High-Grade Glioma Patients Undergoing Chemoradiation

Официальное название

A Feasibility Study of Interim PET-MRI in High-grade Glioma Patients Undergoing Chemoradiation

Обзор

The purpose of this research study is to see if investigators can predict how brain functioning changes after radiation treatment based on PET scans and blood tests. Most participants experience at least mild decreases in their memory or attention after radiation therapy. Investigators hope that PET scans, lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.

Подробное описание

Primary Objective: To determine the feasibility of interim PET-MRI in high-grade glioma patients undergoing chemoradiation by quantifying the proportion of high-grade glioma patients who are alive at 4 months post-radiation treatment and who have completed two PET scans and abbreviated cognitive testing pre-radiation treatment and at 4 months post radiation treatment.

Secondary Objectives

* To determine by machine learning if early changes on FDG-PET correlate with cognitive decline after radiation treatment. Cognitive impairment will be defined as a 1 standard deviation decline on any test. * To determine if baseline serum or cerebrospinal fluid markers or the change from baseline to 1-month are associated with patients with cognitive decline at 4-months after radiation treatment (defined as a 1 standard deviation decline on any test) compared to those without decline.

Вмешательства

• Процедура PET-MRI Brain Scan
  Before starting radiation, participants will have a PET scan and MRI scan of the brain. After 2 to 3 weeks of radiation treatments, participants will have a repeat PET scan. Then 1 month after radiation participants will have another PET scan
• Диагностический тест Blood draw
  Blood draws will be taken at baseline, one month after radiation treatment and 3 to 4 months after radiation treatment.
• Поведенческое Memory testing
  3 sessions with simple tests to evaluate how the brain is working. These tests primarily check things like memory, attention, and thought process. The whole set of tests will take 1 hour each time.
• Процедура Optional lumbar puncture for cerebrospinal fluid collection
  Participants that consent for cerebrospinal fluid collection will have 6 and 20 ml of cerebrospinal collected at baseline.

Первичные конечные точки

• Number of Participants to Complete Two PET scans [Срок оценки: At baseline and at 4 months post-treatment]
• Number of Participants to Complete Cognitive Testing [Срок оценки: At baseline and at 4 months post-treatment]

Вторичные конечные точки (2)

• Change in PET measure Related to Cognitive Decline after Radiation Treatment [Срок оценки: At baseline and 4 months post-treatment]
• Change in Cerebrospinal Fluid (CSF) Biomarkers Related to Cognitive Decline after Radiation Treatment [Срок оценки: At baseline and 4 months post-treatment]

Критерии участия

Критерии включения

• Pathologically confirmed diagnosis of high-grade glioma (grade III or IV) or WHO grade II glioma, IDH wildtype (molecular glioblastoma multiforme \[GBM\]).
• ≥18 years of age.
• ECOG performance status of 0 to 3
• Anticipated to receive 6 weeks of chemoradiation

Критерии исключения

• Does not speak or read English
• Unable to participate in cognitive testing due to aphasia or other severe cognitive impairment as determined by the PI, or Dr. Cummings or her designee.
• Unable to give informed consent
• Past medical history of any kind of dementia or diagnosed with mild cognitive impairment prior to diagnosis with their brain tumor
• Unable to safely fast for 8 hours prior to bloodwork or 6 hours prior to PET scan
• Currently taking cognition-enhancing medications including:

• Donepezil
• Memantine
• Armodafinil
• Methylphenidate
• Pregnant or nursing mothers.
• Patients taking blood thinners will be excluded from the optional Lumbar Puncture only, they are eligible for participation in the main study-provided they meet inclusion/exclusion criteria

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

Диагностика

Центры проведения

США · 1 центр

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Идентификаторы

NCT: NCT05212272 · IRB00080134 · WFBCCC 91221 · P30CA012197

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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