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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluorine F 18 fluorothymidine
positron emission tomography
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain and Central Nervous System Tumors focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Cancer Center at University of Washington Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 12, 2006
Last Updated
February 25, 2019
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00276770
Brief Title
Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
fluorine F 18 fluorothymidine
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander M. Spence, MD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
Facility Information:
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18543042
Citation
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.
Results Reference
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Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas

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