Status:
COMPLETED
Clinical Evaluation of the New Hypoxia Imaging Agent HX4
Lead Sponsor:
Siemens Molecular Imaging
Collaborating Sponsors:
Fudan University
Conditions:
Head and Neck Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 clin...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01213030
Start Date
June 1 2009
End Date
May 1 2010
Last Update
September 25 2012
Active Locations (1)
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1
PET Center, Huashan Hospital, Fudan University
Shanghai, China, 200235