Brain and Central Nervous System TumorsNCT00276770
Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
A study testing fluorine F 18 fluorothymidine and positron emission tomography in people with Brain and Central Nervous System Tumors, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- fluorine F 18 fluorothymidine and positron emission tomography
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043
About this study
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
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.
Read the 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
- Being tested
- fluorine F 18 fluorothymidine, positron emission tomography
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Astrocytoma, Ependymoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorine F 18 fluorothymidineOther
positron emission tomographyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexander M. Spence, MD, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276770
- Sponsor's protocol ID
- 27318
- Other IDs
- UW-6230, NCI-7223
- Status last verified
- Feb 2019
- First submitted
- 12 Jan 2006
- Last updated
- 27 Feb 2019
- Results posted
- No
Publications
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.
PubMed 18543042
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00276770
- Acronym / sponsor ID
- 27318
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006
- Primary completion
- May 2007 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorine F 18 fluorothymidine | Other | – |
| positron emission tomography | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Results publication: PubMed 18543042Spence 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander M. Spence, MD study chair
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluorine F 18 fluorothymidine and positron emission tomography in people with Brain and Central Nervous System Tumors, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019; AzTrials last refreshed its copy on 1 Nov 2026.