Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients … (NCT00276770) | Clinical Trial Compass
CompletedNot Applicable
Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
United States12 participantsStarted 2006-02
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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…