- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659126
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
Study Overview
Status
Intervention / Treatment
- Drug: Ferumoxytol
- Procedure: 3 Tesla Magnetic Resonance Imaging
- Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
- Drug: Gadolinium
- Procedure: High Field Strength Magnetic Resonance Imaging
- Procedure: Susceptibility Weighted Imaging
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects with radiographically suspected, histologically or cytologically confirmed primary brain tumors or brain metastasis are eligible
- Subjects may be enrolled at any point in diagnosis or treatment
- Subjects must have had radiographically evaluable or measurable disease with standard magnetic resonance (MR) imaging
- Members of all races and ethnic groups will be included
- Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky performance status [KPS] >= 30)
- Ability to understand and the willingness to sign a written informed consent document, or have a representative able to consent for the subject
- 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
- Subject agrees to complete follow up visit
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
- Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, need monitored anesthesia for scanning, or have an allergy to Gd contrast material
- Subjects with known hepatic insufficiency or cirrhosis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol
- Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
- Subjects expecting to undergo surgery between the imaging sessions; subjects may undergo surgery at any time before the first, or after the last imaging session; this exclusion only applies to each study visit (3 day scanning session), and does not apply to the time (at least 3 weeks) between each study visit
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating women are excluded from this study
- Inability or unwillingness to undergo the complete series of imaging sessions; inability or unwillingness to complete the one month follow-up
- Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
- Subjects with glomerular filtration rate (GFR) < 50
- Subjects with three or more drug allergies from separate drug classes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (Gd, ferumoxytol, 3T or 7T MRI)
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.
|
Given IV
Other Names:
Undergo 3T MRI
Other Names:
Undergo DCE MRI
Other Names:
Undergo DSC MRI
Other Names:
Given IV
Other Names:
Undergo 7T MRI
Other Names:
Undergo SWI
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Baseline to day 1
|
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.
|
Baseline to day 1
|
CNR, in Terms of Normalized Signal Intensity Changes, for Dynamic Susceptibility Contrast (DSC) MRI Data Sets at 3T and 7T (Gadolinium and Ferumoxytol)
Time Frame: Day 1 to day 2
|
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). |
Day 1 to day 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relevant Dynamic MRI (Dynamic Contrast Enhancement [DCE] and DSC) Signal Intensity Changes for Permeability and Perfusion
Time Frame: Day 1 to day 2
|
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).
|
Day 1 to day 2
|
Change in Cerebral Blood Volume (CBV) Measurements, Quantified Using DSC Techniques
Time Frame: Day 1 to day 2
|
Blood volumes will be compared using repeated measures ANOVA to compare the imaging agents.
|
Day 1 to day 2
|
Change in Tumor Microvascularity on Susceptibility-weighted Images (SWI) Before and After Ferumoxytol
Time Frame: Day 1 to day 2
|
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.
|
Day 1 to day 2
|
Presence of Iron Staining
Time Frame: At time of surgery
|
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.
|
At time of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edward Neuwelt, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00002864 (Other Identifier: OHSU Knight Cancer Institute)
- NCI-2015-00225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- SOL-06077-L
- R01CA137488 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Malignant Neoplasm in the Brain
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Metastatic Malignant Neoplasm in the LungUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingMalignant Solid Neoplasm | Metastatic Malignant Neoplasm in the BrainUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedMalignant Neoplasm | Metastatic Malignant Neoplasm in the BrainUnited States
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingMetastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the BrainUnited States
-
Sameek RoychowdhuryNational Cancer Institute (NCI)WithdrawnLocally Advanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | ALK Gene Mutation | Metastatic Malignant Neoplasm in the Brain | Advanced Malignant Neoplasm | ALK Fusion Protein Expression | Metastatic Malignant Neoplasm in the Central Nervous System | ROS1 Gene Mutation | ALK Gene... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Unresectable Solid NeoplasmUnited States, Canada
-
Northwestern UniversityNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | Metastatic Malignant Neoplasm in the Brain | Metastatic Malignant Neoplasm in the LeptomeningesUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Carcinoma in the Liver | Metastatic Carcinoma in the Lung | Metastatic Malignant Neoplasm in the Thoracic CavityUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI); California Institute for Regenerative Medicine...RecruitingBreast Cancer | HER2-positive Breast Cancer | Malignant Neoplasm | Metastatic Malignant Neoplasm in the Brain | Metastatic Malignant Neoplasm in the LeptomeningesUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm in the Bone | Metastatic Malignant NeoplasmUnited States
Clinical Trials on Ferumoxytol
-
Michael IvNational Cancer Institute (NCI)WithdrawnChildhood Brain NeoplasmUnited States
-
Allegheny Singer Research Institute (also known...Active, not recruitingLiver Neoplasms | Hepatocellular Carcinoma | Liver Metastases | Liver Cancer | Liver Carcinoma | Hepatocellular Cancer | Hepatic Cirrhosis | Hepatic Carcinoma | Hepatic AtrophyUnited States
-
Massachusetts General HospitalCompletedPapillary Carcinoma of Thyroid Gland | Metastatic Medullary Thyroid Cancer | Follicular Thyroid Cancer Lymph Node MetastasisUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Radiological Society of North AmericaTerminatedStage III Rectal Cancer AJCC v7 | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Locally Advanced Rectal CarcinomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science University; National... and other collaboratorsRecruitingPancreatic Adenocarcinoma | Familial Pancreatic Cancer | Pancreatic Intraductal Papillary-Mucinous NeoplasmUnited States
-
Michael IvCompletedBrain Injury | Brain Cancer | Brain Tumors | Primary Brain Neoplasm | Ischemic Cerebrovascular Accident | Central Nervous System Degenerative Disorder | Central Nervous System Infectious Disorder | Central Nervous System Vascular Malformation | Hemorrhagic Cerebrovascular AccidentUnited States
-
Dana-Farber Cancer InstituteWithdrawn
-
AMAG Pharmaceuticals, Inc.UnknownPeripheral Arterial Disease (PAD)United States
-
National Cancer Institute (NCI)CompletedProstate CancerUnited States
-
University of EdinburghRoyal Brompton & Harefield NHS Foundation Trust; Royal Infirmary of Edinburgh; Golden Jubilee National HospitalCompletedMyocarditis | Healthy Volunteers | Cardiac Transplant | Cardiac SarcoidUnited Kingdom