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Sponsors and Collaborators: |
University of Washington National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00276770 |
RATIONALE: Diagnostic procedures, such as positron emission tomography using fluorothymidine F 18, may be effective in finding recurrent disease in patients with gliomas.
PURPOSE: This clinical trial is studying how well positron emission tomography using fluorothymidine F 18 works in finding recurrent disease in patients with gliomas.
Condition | Intervention |
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Brain and Central Nervous System Tumors |
Other: 3'-deoxy-3'-[18F]fluorothymidine Procedure: positron emission tomography |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized |
Official Title: | NCI-Sponsored Trial for the Evaluation of Safety and Preliminary Efficacy Using [F18] Fluorothymidine (FLT) As a Marker of Proliferation in Patients With Primary Brain Tumors |
Estimated Enrollment: | 12 |
Study Start Date: | February 2006 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, nonrandomized study.
Patients receive fluorothymidine F 18 IV over 1 minute and then undergo positron emission tomography (PET) scanning of the brain over 2 hours.
After completion of the PET scan, patients are followed for at least 1 month.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Radiological or established histological diagnosis of glioma
Presence of a new or enlarging enhancing lesion on gadolinium-enhanced MRI after prior radiotherapy
No clinically significant signs of uncal herniation, including any of the following:
PATIENT CHARACTERISTICS:
Female patients must be postmenopausal for ≥ 1 year or surgically sterile, or on 1 of the following methods of birth control for ≥ 1 month: IUD, oral contraceptives, Depo-Provera, or Norplant
PRIOR CONCURRENT THERAPY:
United States, Washington | |
University Cancer Center at University of Washington Medical Center | |
Seattle, Washington, United States, 98195-6043 |
Study Chair: | Alexander M. Spence, MD | University of Washington |
Study ID Numbers: | CDR0000455011, UW-6230, NCI-7223 |
Study First Received: | January 12, 2006 |
Last Updated: | May 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00276770 History of Changes |
Health Authority: | United States: Federal Government |
adult anaplastic astrocytoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult diffuse astrocytoma adult glioblastoma adult giant cell glioblastoma |
adult gliosarcoma adult ependymoma adult oligodendroglioma recurrent adult brain tumor adult mixed glioma |
Signs and Symptoms Brain Neoplasms Glioblastoma Astrocytoma Oligodendroglioma Glioma |
Central Nervous System Neoplasms Gliosarcoma Recurrence Ependymoma Nervous System Neoplasms |
Neoplasms Neoplasms by Site Nervous System Diseases Central Nervous System Neoplasms Nervous System Neoplasms |