Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System

Официальное название

The Feasibility of Steady State CBV Mapping Using Ferumoxytol Immediately After Gadolinium Enhanced MRI of the CNS

Обзор

This phase II trial studies how well gadolinium and ferumoxytol magnetic resonance imaging (MRI) work in diagnosing patients with abnormalities in the central nervous system. Diagnostic procedures, such as gadolinium and ferumoxytol MRI, may help find and diagnose abnormalities in the central nervous system.

Подробное описание

PRIMARY OBJECTIVES:

I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol.

II. To test signal changes of T2\*w multi-echo fast field echo (mFFE) scans before and after contrast agent injection.

SECONDARY OBJECTIVES:

I. To test if ferumoxytol affects gadolinium enhanced MRI. II. To test if steady state cerebral blood volume (CBV) maps are different at various magnetic field strengths.

EXPLORATORY OBJECTIVES:

I. To explore late ferumoxytol enhancement (optional MRI) hours to days after ferumoxytol administration in various brain pathologies.

II. To evaluate the effects of ferumoxytol on malignant and non-malignant lesions in head \& neck, and liver lesions

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive gadolinium intravenously (IV) and then ferumoxytol IV and undergo MRI over 60 minutes on day 1.

GROUP II: Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1.

Вмешательства

• Препарат Ferumoxytol
  Given IV
• Препарат Gadolinium
  Given IV
• Процедура Magnetic Resonance Imaging
  Undergo MRI

Первичные конечные точки

• Visualization of normal vasculature [Срок оценки: Up to 5 years]
• Visualization of abnormal vasculature [Срок оценки: Up to 5 years]
• Visualization of normal anatomical structures [Срок оценки: Up to 5 years]
• Identification of the lesion corresponding areas on cerebral blood volume (CBV) maps [Срок оценки: Up to 5 years]

Вторичные конечные точки (3)

• Contrast enhancement [Срок оценки: Up to 5 years]
• Border delineation [Срок оценки: Up to 5 years]
• Internal morphology [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Subjects must have one of the following:

• Neurological findings (i.e. headache, loss of consciousness, paresis, cranial neuropathy, seizures, etc.)
• Radiological abnormalities in the brain (neoplastic or non-neoplastic in nature)
• Neoplastic process elsewhere in the body that may affect the brain (i.e. possible metastasis, vascular compromise, treatment related changes, etc.)
• Subjects must be able to undergo MRI imaging without anesthesia
• Subjects must be at least 10 years of age
• All subjects, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
• Sexually active women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; surgical intervention i.e. tubal ligation or vasectomy; post-menopausal < 6 months; or abstinence) for at least two months after each cycle of the study; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Критерии исключения

• Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
• Subjects with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations (Ferumoxytol Investigator's Drug Brochure, 2009); subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion
• Subjects who are pregnant or lactating or who suspect they might be pregnant
• Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
• Subjects with known iron overload (genetic hemochromatosis); in subjects with a family history of hemochromatosis, hemochromatosis must be ruled out prior to study entry with normal values of the following blood tests: transferrin saturation (TS) test and serum ferritin (SF) test; all associated costs will be paid by the study
• Subject who have received ferumoxytol within 3 weeks of study entry
• Subjects with three or more drug allergies from separate drug classes

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• OHSU Knight Cancer Institute — Portland

Идентификаторы

NCT: NCT03270059 · STUDY00017028 · NCI-2017-01460 · STUDY00017028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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