Metastatic Malignant Neoplasm in the BrainPhase 2NCT00659126
Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors
A Phase 2 study testing 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging in people with Metastatic Malignant Neoplasm in the Brain and Primary Brain Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Brain, Primary Brain Neoplasm
- What is being tested?
- 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2006to 31 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Ferumoxytol, Gadolinium
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Tesla Magnetic Resonance ImagingProcedure or surgery
Also called 3 Tesla MRI, 3T MRI
Undergo 3T MRI
Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Undergo DCE MRI
Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery
Also called DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRI, DYNAMIC SUSCEPTIBILITY-CONTRAST MRI
Undergo DSC MRI
FerumoxytolDrug
Also called Feraheme, Ferumoxytol Non-Stoichiometric Magnetite
Given IV
GadoliniumDrug
Also called Gd
Given IV
High Field Strength Magnetic Resonance ImagingProcedure or surgery
Also called High Field Strength MRI
Undergo 7T MRI
Susceptibility Weighted ImagingProcedure or surgery
Also called BOLD Venographic Imaging, BOLD Venography, SWI
Undergo SWI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) | Experimental | 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. Receives: Procedure: 3 Tesla Magnetic Resonance Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol; Drug: Gadolinium; Procedure: High Field Strength Magnetic Resonance Imaging; Procedure: Susceptibility Weighted Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 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)
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).
Measured: Day 1 to day 2
Secondary outcomes (4)
Relevant Dynamic MRI (Dynamic Contrast Enhancement [DCE] and DSC) Signal Intensity Changes for Permeability and Perfusion
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).
Measured: Day 1 to day 2
Change in Cerebral Blood Volume (CBV) Measurements, Quantified Using DSC Techniques
Blood volumes will be compared using repeated measures ANOVA to compare the imaging agents.
Measured: Day 1 to day 2
Change in Tumor Microvascularity on Susceptibility-weighted Images (SWI) Before and After Ferumoxytol
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.
Measured: Day 1 to day 2
Presence of Iron Staining
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.
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study start16 Nov 2006
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Malignant Neoplasm in the BrainStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Neuwelt, OHSU Knight Cancer Institute
- Investigators
- Edward Neuwelt, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659126
- Sponsor's protocol ID
- IRB00002864
- Other IDs
- NCI-2015-00225, SOL-06077-L, IRB00002864, R01CA137488
- Status last verified
- Aug 2023
- First submitted
- 10 Apr 2008
- Last updated
- 7 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00659126
- Acronym / sponsor ID
- IRB00002864
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 40 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Oregon Health and Science University
- Study start
- 16 Nov 2006 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 7 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) | Experimental | Procedure: 3 Tesla Magnetic Resonance Imaging, Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, Drug: Ferumoxytol, Drug: Gadolinium, Procedure: High Field Strength Magnetic Resonance Imaging, Procedure: Susceptibility Weighted ImagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 Tesla Magnetic Resonance ImagingAlso: 3 Tesla MRI, 3T MRIUndergo 3T MRI | Procedure or surgery | Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) |
| Dynamic Contrast-Enhanced Magnetic Resonance ImagingAlso: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRIUndergo DCE MRI | Procedure or surgery | Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) |
| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance ImagingAlso: DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRI, DYNAMIC SUSCEPTIBILITY-CONTRAST MRIUndergo DSC MRI | Procedure or surgery | Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) |
| FerumoxytolAlso: Feraheme, Ferumoxytol Non-Stoichiometric MagnetiteGiven IV | Drug | Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) |
| GadoliniumAlso: GdGiven IV | Drug | Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) |
| High Field Strength Magnetic Resonance ImagingAlso: High Field Strength MRIUndergo 7T MRI | Procedure or surgery | Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) |
| Susceptibility Weighted ImagingAlso: BOLD Venographic Imaging, BOLD Venography, SWIUndergo SWI | Procedure or surgery | Diagnostic (Gd, ferumoxytol, 3T or 7T MRI) |
Primary outcome
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.
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).
4 secondary outcomes
Relevant Dynamic MRI (Dynamic Contrast Enhancement [DCE] and DSC) Signal Intensity Changes for Permeability and Perfusion
Time frame: Day 1 to day 2
Change in Cerebral Blood Volume (CBV) Measurements, Quantified Using DSC Techniques
Time frame: 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
Presence of Iron Staining
Time frame: At time of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Neuwelt principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3 Tesla Magnetic Resonance Imaging, Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging in people with Metastatic Malignant Neoplasm in the Brain and Primary Brain Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.