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Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
This study has been completed.
First Received: January 12, 2006   Last Updated: May 15, 2009   History of Changes
Sponsors and Collaborators: University of Washington
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00276770
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 12
Study Start Date: February 2006
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety of fluorothymidine F 18 for visual and dynamic brain tumor images in patients with glial neoplasms.
  • Determine, preliminarily, the efficacy of this drug.

Secondary

  • Compare, preliminarily, the efficacy of this drug to fludeoxyglucose F 18 in differentiating tumor recurrence from radiation necrosis.
  • Determine the optimal time to image post injection of this drug.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Radiological or established histological diagnosis of glioma

    • WHO grade 2-4 disease
  • Presence of a new or enlarging enhancing lesion on gadolinium-enhanced MRI after prior radiotherapy

    • Differentiation of recurrent tumor from radiation necrosis is not possible
  • No clinically significant signs of uncal herniation, including any of the following:

    • Acute pupillary enlargement
    • Rapidly developing (i.e., over hours) motor changes
    • Rapidly decreasing level of consciousness

PATIENT CHARACTERISTICS:

  • Platelet count ≥ 75,000/mm^3
  • WBC ≥ 3,000/mm^3
  • Gamma-glutamyl-transferase ≤ 5 times upper limit of normal (ULN)
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 10 g/dL
  • SGOT and SGPT ≤ 2 times ULN
  • Alkaline phosphatase ≤ 2 times ULN
  • Lactic dehydrogenase ≤ 2 times ULN
  • Direct and total bilirubin normal
  • Amylase normal
  • Haptoglobin normal
  • Serum electrolytes normal
  • CBC with platelets normal
  • PT, PTT normal
  • BUN and creatinine normal
  • Not pregnant or lactating
  • Urinalysis normal
  • Negative pregnancy test
  • 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

    • These criteria can be waived at the discretion of the investigator if the patient's intracranial tumor is considered life threatening and the 1-month wait required is not in the best interest of the patient
  • No known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals
  • No known HIV positivity
  • Not requiring monitored anesthesia for positron emission tomography scanning

PRIOR CONCURRENT THERAPY:

  • Concurrent biopsy or neurosurgical procedure for diagnostic and/or therapeutic purposes for this cancer allowed
  • Concurrent surgery for this cancer allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00276770

Locations
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
University of Washington
Investigators
Study Chair: Alexander M. Spence, MD University of Washington
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Signs and Symptoms
Brain Neoplasms
Glioblastoma
Astrocytoma
Oligodendroglioma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Recurrence
Ependymoma
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009