NCT01213030

Clinical Evaluation of the New Hypoxia Imaging Agent HX4

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Siemens Molecular Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Head and Neck Cancer
• Lung Cancer
• Liver Cancer

Interventions

Type	Name	Description
DRUG	[F-18] FMISO	10 mCi \[F18\] HX4 and 10 mCi \[F-18\] FMISO within 7 days of each other regardless of sequence
DRUG	[F-18] HX4	10 mCi \[F18\] HX4 and 10 mCi \[F-18\] FMISO within 7 days of each other regardless of sequence

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-01-01
• Completion: 2010-05-01
• First posted: 2010-10-01
• Last updated: 2012-09-25

Locations

1 site across 1 country: China