Brain and Central Nervous System TumorsNCT00005790
Perfusion Magnetic Resonance Imaging in Measuring the Growth of Blood Vessels in Newly Diagnosed Brain Tumors
A study testing laboratory biomarker analysis, biopsy and magnetic resonance imaging in people with Brain and Central Nervous System Tumors, run by Northwestern University.
Trial summary
RATIONALE: Perfusion magnetic resonance imaging may be an effective method of measuring the growth of blood vessels in brain tumors. These measurements may help doctors better diagnose and treat brain tumors. 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?
- laboratory biomarker analysis, biopsy and magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 1996to May 1999
- 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: Newly diagnosed surgically resectable brain tumor
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to tolerate gadopentetate dimeglumine contrast Medically stable
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
About this study
Official title: Perfusion Magnetic Resonance Imaging of Brain Tumors: Correlation With Indicators of Angiogenesis
RATIONALE: Perfusion magnetic resonance imaging may be an effective method of measuring the growth of blood vessels in brain tumors. These measurements may help doctors better diagnose and treat brain tumors.
PURPOSE: Pilot study to determine the effectiveness of perfusion magnetic resonance imaging in measuring the growth of blood vessels in newly diagnosed brain tumors.
Read the detailed description
OBJECTIVES: I. Correlate the findings of perfusion magnetic resonance imaging with known tissue and serum markers of angiogenesis in patients with newly diagnosed surgically resectable brain tumors.
OUTLINE: Patients undergo perfusion magnetic resonance imaging (MRI) scanning with contrast in conjunction with preoperative conventional MRI scanning with contrast. Patients receive gadopentetate dimeglumine IV over 5 seconds prior to perfusion MRI. Gadopentetate dimeglumine is administered at a slower rate prior to conventional MRI. Patients undergo blood draw to determine urokinase type plasminogen activator levels. After completion of perfusion and conventional MRI scanning, brain tumor tissue samples are obtained during surgical resection to determine tumor grade and type and urokinase type plasminogen activator and basic fibroblast growth factor levels. If CSF removal is required during surgery, then CSF samples are collected to determine urokinase type plasminogen activator and basic fibroblast growth factor levels.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- laboratory biomarker analysis, biopsy, magnetic resonance imaging, gadopentetate dimeglumine
- Keywords
- adult brain stem glioma, adult ependymoma, adult craniopharyngioma, adult medulloblastoma, adult meningioma, adult glioblastoma, adult oligodendroglioma, adult anaplastic astrocytoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, adult pineal parenchymal tumor, adult central nervous system germ cell tumor, adult pilocytic astrocytoma, adult subependymoma, adult diffuse astrocytoma, adult ependymoblastoma, adult pineocytoma, adult pineoblastoma
- Medical subject headings
- Central Nervous System Neoplasms, Ependymoma, Craniopharyngioma, Medulloblastoma, Meningioma, Glioblastoma, Oligodendroglioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
biopsyProcedure or surgery
magnetic resonance imagingProcedure or surgery
gadopentetate dimeglumineRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study startApr 1996
- Primary completionMay 1999
- Study completionMay 1999
Why it stopped: Unable to accrue subjects.
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 Northwestern UniversityThe 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
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hunt H. Batjer, MD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005790
- Sponsor's protocol ID
- NU 95C1
- Other IDs
- NU-95C1, NCI-G00-1738
- Status last verified
- Jun 2012
- First submitted
- 2 Jun 2000
- Last updated
- 11 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion Magnetic Resonance Imaging of Brain Tumors: Correlation With Indicators of Angiogenesis
- ClinicalTrials.gov ID
- NCT00005790
- Acronym / sponsor ID
- NU 95C1
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult brain stem glioma, adult ependymoma, adult craniopharyngioma, adult medulloblastoma, adult meningioma, adult glioblastoma, adult oligodendroglioma, adult anaplastic astrocytoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to accrue subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1996
- Primary completion
- May 1999
- Study completion
- May 1999
- First posted
- 9 Jun 2004 (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: Perfusion magnetic resonance imaging may be an effective method of measuring the growth of blood vessels in brain tumors. These measurements may help doctors better diagnose and treat brain tumors.
PURPOSE: Pilot study to determine the effectiveness of perfusion magnetic resonance imaging in measuring the growth of blood vessels in newly diagnosed brain tumors.
Detailed description
OBJECTIVES: I. Correlate the findings of perfusion magnetic resonance imaging with known tissue and serum markers of angiogenesis in patients with newly diagnosed surgically resectable brain tumors.
OUTLINE: Patients undergo perfusion magnetic resonance imaging (MRI) scanning with contrast in conjunction with preoperative conventional MRI scanning with contrast. Patients receive gadopentetate dimeglumine IV over 5 seconds prior to perfusion MRI. Gadopentetate dimeglumine is administered at a slower rate prior to conventional MRI. Patients undergo blood draw to determine urokinase type plasminogen activator levels. After completion of perfusion and conventional MRI scanning, brain tumor tissue samples are obtained during surgical resection to determine tumor grade and type and urokinase type plasminogen activator and basic fibroblast growth factor levels. If CSF removal is required during surgery, then CSF samples are collected to determine urokinase type plasminogen activator and basic fibroblast growth factor levels.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| biopsy | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| gadopentetate dimeglumine | Radiation | – |
Primary outcome
Not reported in the source record.
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 11 Jun 2012.
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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.
Hunt H. Batjer, MD study chair
Robert H. Lurie Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing laboratory biomarker analysis, biopsy and magnetic resonance imaging in people with Brain and Central Nervous System Tumors, run by Northwestern University.
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 11 Jun 2012. 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.
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 11 Jun 2012.