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Clinical Evaluation of the New Hypoxia Imaging Agent HX4

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ClinicalTrials.gov Identifier: NCT01213030
Recruitment Status : Completed
First Posted : October 1, 2010
Last Update Posted : September 25, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Lung Cancer Liver Cancer Drug: [F-18] FMISO Drug: [F-18] HX4 Phase 1 Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the New Hypoxia Imaging Agent HX4
Study Start Date : June 2009
Primary Completion Date : January 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 10 mCi HX4
Patient will be injected with [F-18] FMISO
Drug: [F-18] HX4
10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence
Active Comparator: 10 mCi FMISO
Patient will be injected with [F-18] HX4
Drug: [F-18] FMISO
10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence


Outcome Measures

Primary Outcome Measures :
  1. Efficacy of a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Resolution, signal to background ratio, and tumor/blood ratio of PET images with [F-18] FMISO and [F-18]HX4 [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient may be male or female and of any race / ethnicity
  • Patient is > 18 years old at the time of investigational product administration
  • Patient or patient's legally acceptable representative provides written informed consent
  • Patient is capable of complying with study procedures
  • Patient is capable of communicating with study personnel
  • Patient must have histologically confirmed stage III, or IV squamous cell carcinoma of the head and neck whose primary origin was from the oral cavity, oropharynx, hypopharynx, or larynx.
  • According to the Karnofsky Performance Status Scale, the patient has a value of ≥ 60% at time of screening
  • Patient must have normal organ and renal function as defined:

    • total bilirubin within normal institutional limits
    • AST(SGOT)/ALT(SGPT) less than or equal to 2.5 x institutional upper limits of normal
    • creatinine within normal institutional limits
    • BUN within normal institutional limits
    • PT and PTT < 2.0 x institutional upper limits of normal

Exclusion Criteria:

  • Patient is younger than 18 years old at the time of investigational product administration
  • Female patient is pregnant or has a positive serum pregnancy test
  • Patient is unable to remain still for duration of imaging procedure
  • Patient has a history of significant renal disease
  • Patient has previously received [F-18]HX4 at any time, or any other investigational product in the past thirty days.
  • Patient has been involved in an investigative, radioactive research procedure within the past year
  • Inadequate tumor sites or volume to allow for biopsy
  • Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete and good quality data
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213030


Locations
China
PET Center, Huashan Hospital, Fudan University
Shanghai, China, 200235
Sponsors and Collaborators
Siemens Molecular Imaging
Fudan University
Investigators
Principal Investigator: Yi Hui Guan, MD PET Center, Huashan Hospital, Fudan University
More Information

Responsible Party: Yi Hui Guan, PET Center, Huashan Hospital, Fudan University, Shanghai, China 200235, Fudan University
ClinicalTrials.gov Identifier: NCT01213030     History of Changes
Other Study ID Numbers: HX4-FMISO
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: September 25, 2012
Last Verified: September 2012

Keywords provided by Yi Hui Guan, Fudan University:
HX4
[F-18]HX4
FMISO
[F-18]FMISO
Solitary Tumor
Hypoxia

Additional relevant MeSH terms:
Head and Neck Neoplasms
Liver Neoplasms
Hypoxia
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms