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Clinical Evaluation of the New Hypoxia Imaging Agent HX4

NCT01213030 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-09-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Siemens Molecular Imaging

    lead INDUSTRY

Principal Investigators

  • Yi Hui Guan, MD · PET Center, Huashan Hospital, Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-01-31
Completion
2010-05-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213030 on ClinicalTrials.gov