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

February 25, 2019 updated by: University of Washington

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195-6043
        • University Cancer Center at University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Alexander M. Spence, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27318
  • UW-6230
  • NCI-7223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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