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Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases

16. května 2022 aktualizováno: Edward Neuwelt, OHSU Knight Cancer Institute

NCI-Sponsored Multi-Disciplinary Study for MR Imaging of Intravenous Superparamagnetic Crystalline Particle Ferumoxytol in Primary High-Grade Brain Tumors and/or Cerebral Metastases

This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

PRIMARY OBJECTIVES:

I. Investigate the utility of ferumoxytol and gadolinium-based contrast agent (GBCA) for improved imaging biomarkers of malignant brain tumors in a single imaging session by comparing dynamic susceptibility contrast (DSC) determined relative cerebral blood volume (rCBV) and dynamic contrast enhancement (DCE) determined vascular permeability (derived transfer coefficient [Ktrans]).

SECONDARY OBJECTIVES:

I. Compare and evaluate magnetic resonance angiography (MRA) with ferumoxytol between different time points.

II. Assess number and size of tumors imaged. III. Assess tumor vascularity. IV. Assess histology and electron microscopy (EM) on tissue samples. V. Assess differences in subjects with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).

VI. Assess the long term imaging characteristics of different tumors using DSC and DCE.

OUTLINE:

Patients receive ferumoxytol non-stoichiometric magnetite intravenously (IV) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients also undergo MRI without contrast at baseline and on day 2. Imaging with ferumoxytol, GBCA, and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.

After completion of study, patients are followed up at approximately 4-6 weeks.

Typ studie

Intervenční

Zápis (Aktuální)

155

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Oregon
      • Portland, Oregon, Spojené státy, 97239
        • OHSU Knight Cancer Institute

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Subject must have either radiological or established histological diagnosis of the following general categories:

    • High-grade glioma/central nervous system (CNS) lymphoma or
    • Brain metastases
  • Previously untreated subjects must have a lesion on an imaging study
  • Post treatment subjects will have radiographic abnormalities that may or may not be recurrent tumor
  • Subjects agree to be contacted 4-6 weeks after each study visit
  • Subjects, or their legal guardian, 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 and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study treatment and for the duration of study treatment; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Pre-imaging radiological scans/studies must be performed approximately 16 weeks prior to study entry; but not less than 24 hours prior

Exclusion Criteria:

  • 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, 2012); 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 require monitored anesthesia for MRI scanning
  • Subjects with renal insufficiency; glomerular filtration rate (GFR) < 50
  • 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 (Gd) contrast material
  • Subjects with known hepatic insufficiency or cirrhosis
  • Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
  • Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
  • Subjects with three or more drug allergies from separate drug classes

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI)

Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer

Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.

3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI

Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI

Ferumoxytol: Given IV

Gadolinium: Given IV

MRI-Based Angiogram: Undergo MRA
Lék: Ferumoxytol
Vzhledem k tomu, IV
Ostatní jména:
  • Feraheme
  • FERUMOXYTOL NESTOICHIOMETRICKÝ MAGNETIT
Postup: 3 Tesla magnetická rezonance
Podstoupit 3T MRI
Ostatní jména:
  • 3T MRI
  • 3 Tesla MRI
Lék: Gadolinium
Vzhledem k tomu, IV
Ostatní jména:
  • Gd
Postup: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo 3T DCE-MRI
Ostatní jména:
  • DCE-MRI
  • DCE MRI
  • DYNAMICKÁ KONTRASTNÍ MRI
Postup: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Undergo 3T DSC-MRI
Ostatní jména:
  • Dynamická citlivost MRI s kontrastem
Postup: MRI-Based Angiogram
Undergo MRA
Ostatní jména:
  • MRA
  • Magnetická rezonance Angiogram

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans)
Časové okno: Assessed after each visit for up to 6 imaging sessions (up to 5 years)
Appropriate descriptive statistics (mean, standard deviation, minimum, median, and maximum) will be estimated for the imaging parameters Ktrans. Frequency distributions of each parameter will also be described to assess normality. Pearson's correlation coefficients will be estimated to describe potential relationships among these various measures.
Assessed after each visit for up to 6 imaging sessions (up to 5 years)
Utility of Ferumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Imaging Session by Comparing Dynamic Susceptibility Contrast (DSC) Determined Relative Cerebral Blood Volume (rCBV) Maps.
Časové okno: Summarized after completion of up to 6 imaging sessions (up to 5 years)
Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) were obtained. Values range from 0 (low intensity) to 180 (highest intensity).
Summarized after completion of up to 6 imaging sessions (up to 5 years)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Cube Root Volume)
Časové okno: Summarized after completion of up to 6 imaging sessions (up to 5 years)
We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Enhancement volumes normalized to normal appearing white matter were calculated with histogram analysis. Enhancement cube root volumes were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant.
Summarized after completion of up to 6 imaging sessions (up to 5 years)
Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity)
Časové okno: Summarized after completion of up to 6 imaging sessions (up to 5 years)
We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Signal intensities normalized to normal appearing white matter were calculated with histogram analysis. Signal intensities were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. Signal intensities were normalized to the signal intensity value of non-enhancing voxels inside the manual ROI (the relative complement of the final mask in Q, i.e. Q \ [A ∩ B ∩ C]). Higher values in signal intensity indicated increased image enhancement.
Summarized after completion of up to 6 imaging sessions (up to 5 years)
Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI
Časové okno: Assessed after each visit for up to 6 imaging sessions (up to 5 years)
We evaluated overall survival in patients with pseudopregression or real tumor progression by using relative cerebral blood volume values on ferumoxytol enhanced perfusion MRIs.
Assessed after each visit for up to 6 imaging sessions (up to 5 years)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

OHSU Knight Cancer Institute

Spolupracovníci

National Cancer Institute (NCI)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Edward Neuwelt, OHSU Knight Cancer Institute

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. června 2004

Primární dokončení (Aktuální)

10. května 2016

Dokončení studie (Aktuální)

10. června 2016

Termíny zápisu do studia

První předloženo

7. února 2005

První předloženo, které splnilo kritéria kontroly kvality

7. února 2005

První zveřejněno (Odhad)

8. února 2005

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. června 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. května 2022

Naposledy ověřeno

1. května 2022

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB00000813 (Jiný identifikátor: OHSU Knight Cancer Institute)
  • R01CA137488 (Grant/smlouva NIH USA)
  • NCI-2015-00226 (Jiný identifikátor: National Cancer Institute)
  • ONC-03095-LX (Jiný identifikátor: OHSU Knight Cancer Institute)

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na Ferumoxytol

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