NCT00276770

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

January 12, 2006

Last Update Submit

February 25, 2019

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult diffuse astrocytomaadult glioblastomaadult giant cell glioblastomaadult gliosarcomaadult ependymomaadult oligodendrogliomarecurrent adult brain tumoradult mixed glioma

Interventions

fluorine F 18 fluorothymidineOTHER
positron emission tomographyPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Related Publications (1)

  • Spence AM, Muzi M, Link JM, Hoffman JM, Eary JF, Krohn KA. NCI-sponsored trial for the evaluation of safety and preliminary efficacy of FLT as a marker of proliferation in patients with recurrent gliomas: safety studies. Mol Imaging Biol. 2008 Sep;10(5):271-80. doi: 10.1007/s11307-008-0151-6. Epub 2008 Jun 10.

    PMID: 18543042RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsAstrocytomaEpendymomaOligodendrogliomaGlioblastomaGliosarcomaBrain NeoplasmsGlioma

Interventions

alovudineMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Alexander M. Spence, MD

    University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

February 1, 2006

Primary Completion

May 1, 2007

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

US(1)