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Trial record 67 of 96 for:    gadobenate dimeglumine

Perfusion Magnetic Resonance Imaging in Measuring the Growth of Blood Vessels in Newly Diagnosed Brain Tumors

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ClinicalTrials.gov Identifier: NCT00005790
Recruitment Status : Withdrawn (Unable to accrue subjects.)
First Posted : June 9, 2004
Last Update Posted : June 11, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Tracking Information
First Submitted Date  ICMJE June 2, 2000
First Posted Date  ICMJE June 9, 2004
Last Update Posted Date June 11, 2012
Study Start Date  ICMJE April 1996
Primary Completion Date May 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00005790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perfusion Magnetic Resonance Imaging in Measuring the Growth of Blood Vessels in Newly Diagnosed Brain Tumors
Official Title  ICMJE Perfusion Magnetic Resonance Imaging of Brain Tumors: Correlation With Indicators of Angiogenesis
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Diagnostic
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Other: laboratory biomarker analysis
  • Procedure: biopsy
  • Procedure: magnetic resonance imaging
  • Radiation: gadopentetate dimeglumine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June¬†8,¬†2012)
0
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE May 1999
Primary Completion Date May 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00005790
Other Study ID Numbers  ICMJE NU 95C1
NU-95C1
NCI-G00-1738
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Hunt H. Batjer, MD Robert H. Lurie Cancer Center
PRS Account Northwestern University
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP