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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

18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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


- 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

- No known HIV positivity

- Not requiring monitored anesthesia for positron emission tomography scanning


- Concurrent biopsy or neurosurgical procedure for diagnostic and/or therapeutic
purposes for this cancer allowed

- Concurrent surgery for this cancer allowed

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Principal Investigator

Alexander M. Spence, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington


United States: Federal Government

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Brain Neoplasms



University Cancer Center at University of Washington Medical Center Seattle, Washington  98195