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Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00276770
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:

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 or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Other: fluorine F 18 fluorothymidine Procedure: positron emission tomography Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : February 2006
Actual Primary Completion Date : May 2007






Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276770


Locations
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United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Study Chair: Alexander M. Spence, MD University of Washington

Publications of Results:
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00276770     History of Changes
Other Study ID Numbers: 27318
UW-6230
NCI-7223
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

Keywords provided by University of Washington:
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

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