The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.

开始日期2013-03-01

申办/合作机构

Turku University Hospital

NCT02154399 / Completed临床2期IIT

Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-small Cell Lung Cancer

This pilot phase II trial studies how well EF5 works in measuring lack of tumor oxygen, hypoxia, in patients with stage I-III non-small cell lung cancer. EF5 may be effective in measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.

开始日期2002-05-01

申办/合作机构

National Cancer Institute

100 项与 18F-EF5 相关的临床结果

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100 项与 18F-EF5 相关的转化医学

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100 项与 18F-EF5 相关的专利（医药）

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项与 18F-EF5 相关的文献（医药）

2010-11-01·European Journal of Nuclear Medicine and Molecular Imaging1区 · 医学

Biodistribution and dosimetry of 18F-EF5 in cancer patients with preliminary comparison of 18F-EF5 uptake versus EF5 binding in human glioblastoma

1区 · 医学

Article

作者: Judy, Kevin D. ; Divgi, Chaitanya ; Freifelder, Richard ; Reddin, Janet S. ; Scheuermann, Joshua S. ; Kachur, Alexander V. ; Prendergast, Susan ; Koch, Cameron J. ; Smith, Deborah ; Stubbs, James B. ; Driesbaugh, Jason ; Karp, Joel ; Hahn, Stephen M. ; Evans, Sydney M.

PURPOSEThe primary purpose of this study was to assess the biodistribution and radiation dose resulting from administration of (18)F-EF5, a lipophilic 2-nitroimidazole hypoxia marker in ten cancer patients. For three of these patients (with glioblastoma) unlabeled EF5 was additionally administered to allow the comparative assessment of (18)F-EF5 tumor uptake with EF5 binding, the latter measured in tumor biopsies by fluorescent anti-EF5 monoclonal antibodies.METHODS(18)F-EF5 was synthesized by electrophilic addition of (18)F(2) gas, made by deuteron bombardment of a neon/fluorine mixture in a high-pressure gas target, to an allyl precursor in trifluoroacetic acid at 0° then purified and administered by intravenous bolus. Three whole-body images were collected for each of ten patients using an Allegro (Philips) scanner. Gamma counts were determined in blood, drawn during each image, and urine, pooled as a single sample. PET images were analyzed to determine radiotracer uptake in several tissues and the resulting radiation dose calculated using OLINDA software and standard phantom. For three patients, 21 mg/kg unlabeled EF5 was administered after the PET scans, and tissue samples obtained the next day at surgery to determine EF5 binding using immunohistochemistry techniques (IHC).RESULTSEF5 distributes evenly throughout soft tissue within minutes of injection. Its concentration in blood over the typical time frame of the study (∼3.5 h) was nearly constant, consistent with a previously determined EF5 plasma half-life of ∼13 h. Elimination was primarily via urine and bile. Radiation exposure from labeled EF5 is similar to other (18)F-labeled imaging agents (e.g., FDG and FMISO). In a de novo glioblastoma multiforme patient, focal uptake of (18)F-EF5 was confirmed by IHC.CONCLUSIONThese results confirm predictions of biodistribution and safety based on EF5's characteristics (high biological stability, high lipophilicity). EF5 is a novel hypoxia marker with unique pharmacological characteristics allowing both noninvasive and invasive measurements.

100 项与 18F-EF5 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	18F-EF5	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
头颈部鳞状细胞癌	临床2期	芬兰	Turku University Hospital	2013-03-01
肿瘤	临床2期	-	Varian Medical Systems, Inc.	-
肿瘤	临床前	-	University of Pennsylvania	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01774760 (CTgov)	临床2期	头颈部鳞状细胞癌	10	Pretreatment PET/CT-scan (performed two times)+18F-EF5	窪鏇艱廠鏇鏇襯膚鬱鏇(積窪築鹹壓遞鏇窪夢淵) = 廠鹹製觸艱衊鹽壓壓蓋廠製窪構餘鹽獵醖範簾 (壓齋廠構廠願膚衊願醖, 製壓醖觸夢鬱簾繭夢醖 ~ 鏇願遞鹹觸鬱餘鏇壓襯)	-	2019-10-04