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

NCT ID: NCT00276770

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

fluorine F 18 fluorothymidine

Intervention Type: OTHER

positron emission tomography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander M. Spence, MD

Role: STUDY_CHAIR

University of Washington

Locations

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18543042 (View on PubMed)

Other Identifiers

UW-6230

Identifier Type: -

Identifier Source: secondary_id

NCI-7223

Identifier Type: -

Identifier Source: secondary_id

27318

Identifier Type: -

Identifier Source: org_study_id