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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00276770
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Washington
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alexander M. Spence, MD
Principal Investigator Affiliation University of Washington
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Seattle, Washington

Status

Address

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043

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