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Spots Global Cancer Trial Database for Clinical Evaluation of the New Hypoxia Imaging Agent HX4

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Trial Identification

Brief Title: Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Official Title: Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Study ID: NCT01213030

Study Description

Brief Summary: Positron Emission Tomography (PET) with fluorine-18 fluoromisonidazole (FMISO) has been used for several years as a non invasive imaging technique to study tumor hypoxia. Several experimental and clinical studies have indicated that FMISO uptake of tissues is correlated with tissue oxygen tension and that FMSO PET allows non-invasive differentiation between hypoxic and normoxic tumors. Currently, FMISO-PET represents the best characterized and validated noninvasive hypoxia imaging technique. Nevertheless, clinical studies have also shown the limitations of FMISO PET. Accumulation of FMISO in hypoxic tumors is relatively low, resulting in a low contrast between hypoxic tumors and surrounding normal tissues. In addition, imaging needs to be started relatively late after tracer injection (about 3 hours post-injection), when a significant percentage of the fluorine-18 label has already decayed and the count statistics of the PET images are relatively low. Because of these limitations, FMISO PET is still only used at a few research centers, despite high clinical interest in hypoxia imaging.

Detailed Description: Objective of the study The aim of this study is to: * evaluate a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer) * gain information on bio-distribution of \[F-18\]HX4 * compare the PET images of \[F-18\] FMISO to \[F-18\]HX4 for resolution, signal to background ratio, and tumor/blood ratio

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

PET Center, Huashan Hospital, Fudan University, Shanghai, , China

Contact Details

Name: Yi Hui Guan, MD

Affiliation: PET Center, Huashan Hospital, Fudan University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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