Brain and Central Nervous System TumorsNCT00433472
MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial NABTT-9806
A study testing magnetic resonance imaging (MRI) in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Trial summary
RATIONALE: Diagnostic procedures, such as MRI, may help doctors learn how efaproxiral works in the brain and help plan the best treatment. PURPOSE: This clinical trial is using MRI to evaluate the effect of efaproxiral on the brain in patients with recurrent or progressive glioma receiving treatment on clinical trial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- magnetic resonance imaging (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Recurrent or progressive glioma
- Currently enrolled on clinical trial NABTT-9806
PATIENT CHARACTERISTICS:
- No severe claustrophobia
- No cardiac pacemaker
- No MRI-incompatible metallic implant
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806
RATIONALE: Diagnostic procedures, such as MRI, may help doctors learn how efaproxiral works in the brain and help plan the best treatment.
PURPOSE: This clinical trial is using MRI to evaluate the effect of efaproxiral on the brain in patients with recurrent or progressive glioma receiving treatment on clinical trial NABTT-9806.
Read the detailed description
OBJECTIVES:
- Determine whether efaproxiral has a measurable effect on the brain as shown by T2 and/or T2* MRI in patients with recurrent or progressive malignant glioma enrolled on NABTT-9806.
- Determine predicted oxygenation changes based on observed T2 MRI changes in these patients.
- Determine the effects of this drug on T2 and T2* MRI relaxation times of normal areas of the brain in these patients.
- Determine baseline oxygen extraction ratios in tumors of patients treated with this drug.
- Determine whether administration of this drug reveals any new tumor- or non-tumor-related abnormalities on T2 and T2* MRI in these patients.
OUTLINE: This is an open-label, multicenter, pilot study.
Patients receive efaproxiral and carmustine on clinical trial NABTT-9806. During any one course of treatment on that study, patients undergo MRI before oxygen administration (baseline), before efaproxiral infusion, and then every 5 minutes until 1 hour after efaproxiral and carmustine treatment. Data is evaluated for extent and intensity of T2/T2* changes and oxygen concentration changes in both abnormal and normal brain.
PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study within 12-24 months.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- magnetic resonance imaging (MRI)
- Keywords
- adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Oligodendroglioma, Glioblastoma, Astrocytoma, Brain Neoplasms, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging (MRI)Device
Also called MRI
MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI
| Study group | Role | What they receive |
|---|---|---|
| MRI - | Other | MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI
Procedure/surgery magnetic resonance imaging (MRI) Receives: Device: magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI
Predicted oxygenation changes based on observed T2 MRI changes
Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain
Baseline oxygen extraction ratios in tumors
New tumor- or non-tumor-related abnormalities on T2 and T2* MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
Why it stopped: not enough interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 N/A
- Primary purpose
- Diagnosis
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Larry Kleinberg, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433472
- Sponsor's protocol ID
- NABTT-2002 CDR0000274785
- Other IDs
- U01CA062475, P30CA006973, NABTT-2002, JHOC-NABTT-2002, ALLOS-RSR13CT-001i
- Status last verified
- Jul 2015
- First submitted
- 8 Feb 2007
- Last updated
- 29 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806
- ClinicalTrials.gov ID
- NCT00433472
- Acronym / sponsor ID
- NABTT-2002 CDR0000274785
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult gliosarcoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not enough interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 12 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures, such as MRI, may help doctors learn how efaproxiral works in the brain and help plan the best treatment.
PURPOSE: This clinical trial is using MRI to evaluate the effect of efaproxiral on the brain in patients with recurrent or progressive glioma receiving treatment on clinical trial NABTT-9806.
Detailed description
OBJECTIVES:
- Determine whether efaproxiral has a measurable effect on the brain as shown by T2 and/or T2* MRI in patients with recurrent or progressive malignant glioma enrolled on NABTT-9806.
- Determine predicted oxygenation changes based on observed T2 MRI changes in these patients.
- Determine the effects of this drug on T2 and T2* MRI relaxation times of normal areas of the brain in these patients.
- Determine baseline oxygen extraction ratios in tumors of patients treated with this drug.
- Determine whether administration of this drug reveals any new tumor- or non-tumor-related abnormalities on T2 and T2* MRI in these patients.
OUTLINE: This is an open-label, multicenter, pilot study.
Patients receive efaproxiral and carmustine on clinical trial NABTT-9806. During any one course of treatment on that study, patients undergo MRI before oxygen administration (baseline), before efaproxiral infusion, and then every 5 minutes until 1 hour after efaproxiral and carmustine treatment. Data is evaluated for extent and intensity of T2/T2* changes and oxygen concentration changes in both abnormal and normal brain.
PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study within 12-24 months.
Study design
- Primary purpose
- Diagnosis
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI - | Other | Device: magnetic resonance imaging (MRI)MRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI Procedure/surgery magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| magnetic resonance imaging (MRI)Also: MRIMRI scan to be complete to look at RSR13 on measurement of T2 and T2* on MRI | Device | MRI - |
Primary outcome
Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI
Predicted oxygenation changes based on observed T2 MRI changes
Effects of efaproxiral on T2 and T2* MRI relaxation times of normal areas of the brain
Baseline oxygen extraction ratios in tumors
New tumor- or non-tumor-related abnormalities on T2 and T2* MRI
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
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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.
Larry Kleinberg, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging (MRI) in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measurable effect of efaproxiral on the brain as measured by T2 and/or T2* MRI. The study lists 5 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 29 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.