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NCT Number: NCT01213030

Clinical Evaluation of the New Hypoxia Imaging Agent HX4

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.

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Key information

Conditions

Head and Neck Cancer Digestive System Diseases Digestive System Neoplasms Head and Neck Neoplasms Hypoxia Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Signs and Symptoms, Respiratory Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

PET Center, Huashan Hospital, Fudan University

Shanghai, 200235, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[F-18] FMISO

Drug

10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence

[F-18] HX4

Drug

10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Siemens Molecular Imaging

Industry

Collaborators

  • Fudan University

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 1, 2010
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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