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Completed

NCT Number: NCT00276770

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluorine F 18 fluorothymidine

Other

Positron Emission Tomography

Procedure

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
First posted
Jan 13, 2006
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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