Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

Официальное название

Using Advanced MR Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans: A Pilot Study, and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

Обзор

The researchers think that the use of advanced MR imaging may help people with this disease, because it may better predict areas within a malignant glioma (brain tumor) that are at a high risk of recurring. WeThe reserchers are doing this study to see whether this advanced imaging is a safe treatment that causes few or mild side effects in people with brain tumors.

Вмешательства

• Процедура MRI and advanced MRI sequences
  This is a nonrandomized study in which each patient will receive the standard clinical care (in the form of surgery, radiation therapy and/or chemotherapy), as per the treating physician. Surgical resection will be performed at the discretion of the treating Neurooncologist and/or Neurooncology Tumor Board. Advanced brain MRIs with the 2 (or, in some cases, 3) special sequences will be obtained at the time of the clinically scheduled contrast MRIs, which are usually obtained immediately prior to

Первичные конечные точки

• To assess the utility of baseline advanced MRI & changes between baseline & follow up advanced MRI in predicting high risk areas that are likely to develop progressive glioma despite chemoradiotherapy. [Срок оценки: 1 -7 weeks before radiation treatment, about two months after treatment, and about every two months thereafter for the duration of the study.]

Вторичные конечные точки (2)

• To compare radiation therapy simulations in patients with gliomas using conventional and baseline advanced MRI data. [Срок оценки: prior to and 1 months±3 weeks after radiation therapy.]
• feasibility of 2HG spectroscopy [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Suspected or Histopathologically proven diagnosis of high grade or low glioma or tumor is suspected to harbor an isocitrate dehydrogenase (IDH) mutation
• May undergo radiation therapy
• Patient and/or guardian is able to provide written informed consent prior to study registration
• Age ≥ 18 years old

Критерии исключения

• Extreme claustrophobia that precludes MRI scan
• Known allergic reaction to Gd-DTPA
• Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
• Any absolute contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
• Pregnant or nursing female
• Unable to cooperate for MRI and/or radiation therapy planning

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

• Memorial Sloan Kettering Cancer Center — New York

Идентификаторы

NCT: NCT00870129 · 09-009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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