Clinical trial · Interventional
Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas
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
NCT00276770CI-TRIAL-00037307completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorine F 18 fluorothymidine | Other | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSpence 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 18543042