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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Other: fluorine F 18 fluorothymidine
* Procedure: positron emission tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: fluorine F 18 fluorothymidine|nan|
|Procedure: positron emission tomography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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