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.

Start Date01 Mar 2013

Sponsor / Collaborator

Turku University Hospital

NCT02154399 / CompletedPhase 2IIT

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.

Start Date01 May 2002

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with 18F-EF5

100 Translational Medicine associated with 18F-EF5

100 Patents (Medical) associated with 18F-EF5

Literatures (Medical) associated with 18F-EF5

01 Nov 2010·European Journal of Nuclear Medicine and Molecular ImagingQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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 Deals associated with 18F-EF5

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Squamous Cell Carcinoma of Head and Neck	Phase 2	FI	Turku University Hospital	01 Mar 2013
Neoplasms	Phase 2	-	Varian Medical Systems, Inc.	-
Neoplasms	Preclinical	-	University of Pennsylvania	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01774760 (CTgov)	Phase 2	Squamous Cell Carcinoma of Head and Neck	10	Pretreatment PET/CT-scan (performed two times)+18F-EF5	kvawiscgbn(exfruzhual) = utnqxvxbxn mdvzdokgao (bqaqfnnkub, wimplgnrsr - fiabyqauog)	-	04 Oct 2019

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