Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
Status: | Completed |
---|---|
Conditions: | Brain Cancer, Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 3/1/2019 |
Start Date: | February 2006 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
1959 NE Pacific St
Seattle, Washington 98195
Seattle, Washington 98195
(206) 598-4100
University Cancer Center at University of Washington Medical Center The Division of Radiation Oncology's work...
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