Know Cancer

or
forgot password

Clinical Evaluation of the New Hypoxia Imaging Agent HX4


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Lung Cancer, Liver Cancer

Thank you

Trial Information

Clinical Evaluation of the New Hypoxia Imaging Agent HX4


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Efficacy of a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer)

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Yi Hui Guan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

PET Center, Huashan Hospital, Fudan University

Authority:

China: Food and Drug Administration

Study ID:

HX4-FMISO

NCT ID:

NCT01213030

Start Date:

June 2009

Completion Date:

May 2010

Related Keywords:

  • Head and Neck Cancer
  • Lung Cancer
  • Liver Cancer
  • HX4
  • [F-18]HX4
  • FMISO
  • [F-18]FMISO
  • Solitary Tumor
  • Hypoxia
  • Head and Neck Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms
  • Anoxia

Name

Location