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

University of Washington

Status

Completed

Conditions

Brain and Central Nervous System Tumors

Treatments

Procedure: positron emission tomography

Other: fluorine F 18 fluorothymidine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00276770

27318

NCI-7223

UW-6230

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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