Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Siemens

Status and phase

Completed

Phase 2

Phase 1

Conditions

Lung Cancer

Head and Neck Cancer

Liver Cancer

Treatments

Drug: [F-18] HX4

Drug: [F-18] FMISO

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01213030

HX4-FMISO

Details and patient eligibility

About

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.

Full 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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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