Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Lung Cancer Clinical Trial

Official title:

Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213030
• Other study ID #: HX4-FMISO
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 14, 2009
• Last updated: September 20, 2012
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2012
• Source: Siemens Molecular Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Liver Cancer
• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	PET Center, Huashan Hospital, Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Siemens Molecular Imaging	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer)		6 months	Yes
Secondary	Resolution, signal to background ratio, and tumor/blood ratio of PET images with [F-18] FMISO and [F-18]HX4		6 months	Yes