Patient case: 82-year-old male with glioma; genetic feature: BRAF

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

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.

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: 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

Relevance to patient case: not relevant