Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Other Dietary Supplements

All Drugs and Chemicals

Pyruvate

Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.

Hyperpolarized Carbon C 13 Pyruvate

Magnetic Resonance Spectroscopic Imaging

Dawid Schellingerhout

This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.

PRIMARY OBJECTIVES:

I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.

SECONDARY OBJECTIVES:

I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate (kpl) values and Ki-67 quantitation in the tumor.

II. To compare kpl values between tumor and normal brain within patient. III. To assess the association between kpl values and pathology results, including conventional, diffusion, perfusion, and permeability imaging.

IV. To assess the association between kpl values and magnetic resonance (MR) imaging findings.

V. To assess the association between kpl values and genomic findings, including methylation, ribonucleic acid \[RNA\], and deoxyribonucleic acid \[DNA\]).

OUTLINE:

Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and then undergo an MRSI scan.

After completion of study, patients are followed up for 1 day.

Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors

Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation

The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.

Spearman's rank correlation will be used to assess the association between kpl values and Ki-67 if the samples are assumed to be independent. Otherwise, intraclass correlation coefficient (ICC) of random effects models will be used.

Will compare with normal brain kpl values. Linear mixed models will be used.

Will compare with tumor kpl values. Linear mixed models will be used.

Correlation with kpl values will be determined through generalized linear mixed models.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Heart and Blood Diseases

Infections

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Stroke

Inflammation

Communicable Diseases

Congenital Abnormalities

Brain Injuries

Ischemic Stroke

Ischemia

Central Nervous System Infections

Vascular Malformations

Hemorrhagic Stroke

Central Nervous System Vascular Malformations

Craniocerebral Trauma

Trauma, Nervous System

Disease Attributes

Cerebrovascular Disorders

Vascular Diseases

Cardiovascular Abnormalities

Nervous System Malformations

Micronutrients

Hematinics

Pharmaceutical Solutions

Iron

Ferrosoferric Oxide

Parenteral Nutrition Solutions

All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI.

Ferumoxytol

Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.

Tissue Analysis

All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.

Magnetic Resonance Imaging

Michael Iv, MD

This pilot clinical trial study will assess the inflammatory response of brain tumors or other central nervous system conditions in pediatric and adult patients using ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory cells (macrophages) at histopathology. Determining the extent of inflammation associated with pathologies in the central nervous system may be helpful for diagnostic and prognostic purposes as well as monitoring treatment response of current and future immunotherapies.

In this study, we will establish the MR imaging characteristics of macrophages in malignant brain tumors and other CNS conditions in the pediatric and adult populations using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle that is approved for the treatment of iron deficiency anemia in patients with chronic kidney disease. The investigators will correlate the MR signal of ferumoxytol uptake with the number of macrophages in surgical specimen at histopathology. This information may potentially offer clinicians a new means for risk stratification and monitoring treatment efficacy.

Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS

MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI

Michael Iv

Clinical Assistant Professor

Recurrence

Hyperplasia

Anti-Infective Agents

Alovudine

Antiviral Agents

Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.

Computed Tomography

Fluorothymidine F-18

Positron Emission Tomography

Jason Rockhill

This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with brain tumors. Comparing results of diagnostic procedures done before, during, and after treatment may help doctors measure tumor growth and plan the best treatment.

PRIMARY OBJECTIVES:

I. Using FLT PET/CT as a measure of cellular proliferation, assess tissue proliferation in disease sites of brain tumor patients before therapy (surgery, chemotherapy or radiotherapy or any combination of these).

II. Determine level of change in cellular proliferation compared with baseline (scan 1) in brain tumors at mid-therapy (scan 2), after completion of therapy (scan 3) and in the clinical follow-up period (scan 4), when possible.

III. Correlate levels of cellular proliferation measured by FLT PET/CT at baseline and treatment-induced changes in brain tumor proliferation with clinical response status (clinical categories are complete remission, lesser degrees of response/stable disease, and no response).

SECONDARY OBJECTIVES:

I. Assess spatial heterogeneity of FLT uptake to identify local differences in brain tumor disease burden.

OUTLINE:

Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.

After completion of study, patients are followed for up to 7 years.

18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors

Cellular Proliferation Imaging Using [18F] Fluorothymidine (FLT) Positron Emission Tomography (PET) in Brain Tumors

The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.

The percentage change in the kinetic model parameter of FLT transport (K1) was recorded. K1 is defined as the transfer of FLT from blood into tissue (tumor).

The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion.

Time from study entry to death will be recorded

This is clinical response as assessed at physician discretion using standard of care criteria.

University of Washington

This is an imaging study. No adverse events are expected or have been reported due to tracer injection or imaging during the 24 hour monitoring period. All deaths were due to the natural course of cancer after the time period that adverse events were collected for this study.

Diagnostic (18F-FLT PET/CT)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Hannah Linden

Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy

2 Diagnostic (18F-FLT PET/CT)Scans

Patients completing two or three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy

2 or 3 Diagnostic (18F-FLT PET/CT) Scans

4 patients had 2 scans, 2 patients had 3 scans

Percentage Change in Measure of FLT Flux

2 Diagnostic (18F-FLT PET/CT) Scans

Patients completing three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy

4 patients had 2 scans and 2 had 3 scans.

Percentage Change in Measure of Reflecting Transport

Patients undergo two 18F-FLT PET/CT at baseline (pre-therapy) and mid-therapy

Patients undergo three 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy and completion of therapy

Percentage Change in Measure of Standard Uptake Value

All patients with at least one 18F-FLT/CT study

Survival

Data not collected for this Outcome Measure

Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria

Overall Study

Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2. Patients undergo anatomical MRI sequences with 3T or 7T at baseline and on days 1-3. Patients also undergo DSC MRI and DCE MRI on days 1-2. Day 1 and day 2 imaging sessions may be separated by up to 7 days.

3 Tesla Magnetic Resonance Imaging

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Gadolinium

High Field Strength Magnetic Resonance Imaging

Susceptibility Weighted Imaging

Edward Neuwelt

This phase II trial studies how well magnetic resonance imaging (MRI) using contrast imaging agent ferumoxytol works in comparison to standard imaging agent gadolinium in measuring tumors in patients undergoing treatment for brain tumors or other tumors that have spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose disease and find out how far the disease has spread. MRI scans use radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. The contrast imaging agent ferumoxytol consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It is highly visible on the MRI, and may help visualize the blood flow going through the tumor better than gadolinium can. Using a more sensitive and faster 7 Tesla (7T) magnet MRI in conjunction with a contrast imaging agent may provide a better way to measure tumors than the 3 Tesla (3T) magnet MRI in patients with brain tumors.

PRIMARY OBJECTIVES:

I. To compare quantitative blood brain barrier permeability measurements (derived transfer coefficient \[Ktrans\]) of a standard gadolinium (Gd) MRI contrast agent at 3T and 7T using dynamic contrast enhancement (DCE) MRI.

II. To compare dynamic susceptibility contrast (DSC) based perfusion measures at 3T and 7T.

SECONDARY OBJECTIVES:

I. To describe the blood brain barrier permeability to ferumoxytol (ferumoxytol non-stoichiometric magnetite) and to a standard gadolinium-based MRI contrast agent using signal intensity changes as described above.

II. To describe cerebral blood volume (CBV) measurements obtained using a standard gadolinium MRI contrast agent and ferumoxytol.

III. To evaluate tumor microvascularity on susceptibility-weighted images (SWI).

IV. To describe the microscopic distribution of ferumoxytol particles in tissue removed from subjects undergoing surgery.

OUTLINE: Patients are assigned to 3T or 7T magnet within the subgroups.

Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2. Patients undergo anatomical MRI sequences with 3T or 7T at baseline and on days 1-3. Patients also undergo DSC MRI and DCE MRI on days 1-2. Day 1 and day 2 imaging sessions may be separated by up to 7 days.

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

Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors

A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3T and 7T in Subjects With Primary or Metastatic Brain Tumors Either Before or After Therapy

Paired sample t-tests will be used for primary descriptive comparisons. Secondary analyses will use a repeated measures analysis of variance (ANOVA) model to compare 3T and 7T while adjusting for other factors including tumor type, prior therapy, and, potentially, important baseline factors that differ between the subjects assigned to the two field strengths. Normality will be assessed graphically and, if needed, a transformation (e.g. the logarithmic transform) will be applied.

A two sample t-test was used for primary descriptive comparisons since CNR was measured on different subjects at 3T and 7T. There were no repeated measures in the resulting data. Given the small sample size, a linear regression was conducted to compare CNR between 3T and 7T only adjusted for Fe dose. No other adjusted analyses were conducted.

CNR was compared between 3T and 7T for both Ferumoxytol and Gadolinum. Ferumoxytol was administered using three injections and CNR was measured after each injection, thus we have three measures of CNR (Fe1CNR, Fe2CNR and Fe3CNR).

Mixed model repeated measures ANOVAs will be fit. Factors will include imaging agent (Gd or ferumoxytol) and field strength (3T and 7T). Each subject will contribute one measure for each combination of imaging agent and field strength (4 measures total).

Blood volumes will be compared using repeated measures ANOVA to compare the imaging agents.

Analysis will also include covariates of prior therapy. For the comparisons between treated and untreated subjects, means and confidence intervals will be estimated for each group for the perfusion and permeability measures and for the baseline characteristics.

The pathology will be analyzed qualitatively for the presence of iron staining. The amount and localization of the staining will be assessed, with attention paid to whether the tumor cells themselves or reactive cells in and around the tumor demonstrate iron uptake.

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

A subset of subjects with primary or metastatic brain tumors will be assigned to 3 Tesla MRI and will undergo gadolinium enhanced imaging on day 1, ferumoxytol enhanced imaging on day 2, and a non contrast ("post-ferumoxytol") imaging on day 3. All scans will be performed on a 3 Tesla MRI scanner.

Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 3 Tesla in Subjects With Brain Tumors

A subset of subjects with primary or metastatic brain tumors will be assigned to 7 Tesla MRI and will undergo gadolinium enhanced imaging on day 1, ferumoxytol enhanced imaging on day 2, and a non contrast ("post-ferumoxytol") imaging on day 3. All scans will be performed on a 7 Tesla MRI scanner.

Gadolinium and Ferumoxytol Magnetic Resonance Imaging at 7 Tesla in Subjects With Brain Tumors

Total

Glioblastoma

Anaplastic astrocytoma

Astrocytoma grade II

Anaplastic oligodendroglioma

Oligodendroglioma grade II

Meningioma

Metastasis

CNS lymphoma

Other

Brain tumor type

Amy Huddleston

The first primary objective was to use dynamic contrast enhancement (DCE) MRI. Due to limitations of the scanners, these images were not collected. Dynamic susceptibility contrast (DSC) images were collected which are reported in the second primary objective.

Contrast to Noise Ratio (CNR), in Terms of Normalized Signal Intensity Changes, for T1-weighted MRI Signal at 3T and 7T (Gadolinium [Gd] T1-weighted Magnetic Resonance Imaging [MRI] DCE Data Only)

Ferumoxytol 1st dose

Ferumoxytol 2nd dose

Ferumoxytol 3rd dose

Other patients were excluded due to poor DSC graph or no residual tumor for measurement or residual tumor stayed within vascular lumen. Non-contrast (day 3) data not collected.

CNR, in Terms of Normalized Signal Intensity Changes, for Dynamic Susceptibility Contrast (DSC) MRI Data Sets at 3T and 7T (Gadolinium and Ferumoxytol)

Data for secondary outcomes were not collected. The study was terminated early as the 7t scanner was not providing the images needed, and we did not have the funding to continue.

Relevant Dynamic MRI (Dynamic Contrast Enhancement [DCE] and DSC) Signal Intensity Changes for Permeability and Perfusion

Change in Cerebral Blood Volume (CBV) Measurements, Quantified Using DSC Techniques

Change in Tumor Microvascularity on Susceptibility-weighted Images (SWI) Before and After Ferumoxytol

Presence of Iron Staining

Meningeal Neoplasms

Patients complete a survey related to their perceived quality of care via telephone and have their medical chart reviewed prospectively.

Electronic Health Record Review

Survey Administration

Barbara J O'Brien, MD

This study evaluates patient perceptions around quality of care through telemedicine in neuro-oncology. Studying questionnaires related to perceptions quality of care through telemedicine in patients with brain cancer may help doctors to improve the delivery of care through this modality.

PRIMARY OBJECTIVE:

I. To evaluate the patient-perceived quality of care by group (telemedicine versus in-person visits) in patients with central nervous system (CNS) cancer.

SECONDARY OBJECTIVES:

I. To characterize the visits provided by telemedicine compared to those in-person.

II. To contrast the average time spent on telemedicine visits compared to in-person visits, and the delay between visit order placement and visit occurring.

III. To evaluate the domains of patient care addressed on a telemedicine visit versus in-person visit per documentation, including (1) treatment planning, (2) symptom burden, (3) goals of care.

IV. To evaluate frequency of acute care sought (through emergency room or urgent care clinic) within 30 days of encounter in telemedicine visit versus (vs) in-person visit.

V. The impact of patient and clinical characteristics on perceived quality of care in the context of covariate-adjusted modeling.

OUTLINE:

Patients complete a survey related to their perceived quality of care via telephone and have their medical chart reviewed prospectively.

Patient Perceptions Around Quality of Care Through Telemedicine in Neuro-Oncology

Survey responses will be summarized by ordinal category as counts with percentages, separately by group. Will separately estimate the proportion of each ordinal level of each group with 95% confidence interval.

Will separately estimate the proportion of each ordinal level of each group with 95% confidence interval.

Differences between groups will be assessed by 2-sample 2-sided t-test and Mann-Whitney test, Fisher's exact test, or chi-square test.

Will be summarized by group per mean, median, standard deviation, and range. Differences between groups will be assessed by t-test and Mann-Whitney test.

Will be summarized as counts with percentages by group. Differences between groups will be assessed by chi-square test.

Will be summarized as counts with percentages by group. Differences between groups will be provisionally assessed by Fisher's exact test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors	NCT03830151	Primary Brain N...	Hyperpolarized ... Magnetic Resona...	19 Years -	M.D. Anderson Cancer Center
Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS	NCT02452216	Brain Injury Central Nervous... Central Nervous... Central Nervous... Hemorrhagic Cer... Ischemic Cerebr... Primary Brain N... Brain Cancer Brain Tumors	Ferumoxytol Tissue Analysis Magnetic Resona...	2 Years -	Stanford University
18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors	NCT02167204	Metastatic Mali... Primary Brain N... Recurrent Brain...	Computed Tomogr... Fluorothymidine... Positron Emissi...	18 Years -	University of Washington
Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors	NCT00659126	Metastatic Mali... Primary Brain N...	3 Tesla Magneti... Dynamic Contras... Dynamic Suscept... Ferumoxytol Gadolinium High Field Stre... Susceptibility ...	18 Years -	OHSU Knight Cancer Institute
18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors	NCT02167204	Metastatic Mali... Primary Brain N... Recurrent Brain...	Computed Tomogr... Fluorothymidine... Positron Emissi...	18 Years -	University of Washington
Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS	NCT02452216	Brain Injury Central Nervous... Central Nervous... Central Nervous... Hemorrhagic Cer... Ischemic Cerebr... Primary Brain N... Brain Cancer Brain Tumors	Ferumoxytol Tissue Analysis Magnetic Resona...	2 Years -	Stanford University
Patient Perceptions Around Quality of Care Through Telemedicine in Neuro-Oncology	NCT04988009	Central Nervous... Leptomeningeal ... Metastatic Mali... Primary Brain N...	Electronic Heal... Survey Administ...	18 Years -	M.D. Anderson Cancer Center
18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors	NCT02167204	Metastatic Mali... Primary Brain N... Recurrent Brain...	Computed Tomogr... Fluorothymidine... Positron Emissi...	18 Years -	University of Washington
18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors	NCT02167204	Metastatic Mali... Primary Brain N... Recurrent Brain...	Computed Tomogr... Fluorothymidine... Positron Emissi...	18 Years -	University of Washington

Spots Global Cancer Trial Database for primary brain neoplasm