MRE Scan for the Assessment of Differences in Tissue Stiffness Between Radiation Necrosis and Recurrent Glioma in Patients With Previously Treated Gliomas

Официальное название

Pilot Study to Assess Mean Lesion Stiffness of Radiation Necrosis and Recurrent Glioma Using Magnetic Resonance Elastography (MRE) in Patients With Previously Treated Gliomas

Обзор

This trial uses magnetic resonance elastography (MRE) to estimate tissue stiffness (hardness or softness of the tissue) in tissue that is affected by radiation treatment (radiation necrosis) and tumor tissue that has come back (recurrent) after treatment in patients with gliomas. Diagnostic procedures, such as MRE, may estimate the differences in tissue stiffness between radiation necrosis and recurrent glioma post treatment and ultimately lead to a more accurate diagnosis and/or surgery, and/or a better assessment of the disease's response to treatment.

Подробное описание

PRIMARY OBJECTIVES:

I. To estimate the mean lesion stiffness in patients with radiation necrosis using magnetic resonance elastography (MRE).

II. To estimate the mean lesion stiffness in patients with glioma recurrence using magnetic resonance elastography (MRE).

SECONDARY OBJECTIVE:

I. To investigate the mean lesion stiffness between radiation necrosis and glioma recurrence.

OUTLINE:

Patients undergo MRE over 10 minutes and then undergo standard of care magnetic resonance imaging (MRI) of the brain with and without contrast at baseline. Within 4 weeks after the initial MRI and MRE scans, patients may undergo standard of care biopsy to check the status of the disease. Within 48 hours after biopsy, patients undergo standard of care MRI to check the status of the disease. Patients who do not undergo biopsy undergo standard of care MRI 4-8 weeks after MRE scan to check the status of the disease.

Вмешательства

• Процедура Magnetic Resonance Elastography
  Undergo MRE
• Процедура Magnetic Resonance Imaging
  Undergo standard of care MRI

Первичные конечные точки

• Mean lesion stiffness [Срок оценки: At baseline]

Критерии участия

Критерии включения

• >/=18 years old.
• History of a pathology proven intracranial glioma (including IDH mutant, IDH wildtype or 1p19q co-deleted tumors) treated with chemotherapy and radiation.
• The lesion of concern (T2 Flair Hyperintense or contrast enhancing lesion) is > 2 cm
• Patient is able to understand and give consent to participation in the study.

Критерии исключения

• Patients less than 18 years of age.
• Pregnant.
• Known allergy to gadolinium-based contrast agents.
• Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m2.
• Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:

• electronically, magnetically, and mechanically activated implants
• ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
• metallic splinters in the eye
• ferromagnetic hemostatic clips in the central nervous system (CNS) or body
• cochlear implants
• other pacemakers, e.g., for the carotid sinus
• insulin pumps and nerve stimulators
• non-MR safe lead wires
• prosthetic heart valves (if dehiscence is suspected)
• non-ferromagnetic stapedial implants
• claustrophobia that does not readily respond to oral medication

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

• M D Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT04373720 · 2019-1070 · NCI-2020-02247 · 2019-1070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗