Clinical Evaluation of the New Hypoxia Imaging Agent HX4

NCT01213030 | Completed Phase 1 DMC

• 1 other identifier: HX4-FMISO
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Head and Neck Cancer; Lung Cancer; Liver Cancer

Keywords

HX4; [F-18]HX4; FMISO; [F-18]FMISO; Solitary Tumor; Hypoxia

Outcome Measures

Primary Outcomes (1)

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

  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

  6 months

Study Arms (2)

10 mCi HX4

ACTIVE COMPARATOR

Patient will be injected with \[F-18\] FMISO

Drug: [F-18] HX4

10 mCi FMISO

ACTIVE COMPARATOR

Patient will be injected with \[F-18\] HX4

Drug: [F-18] FMISO

Interventions

[F-18] FMISO DRUG

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

10 mCi FMISO

[F-18] HX4 DRUG

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

10 mCi HX4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siemens Molecular Imaging: lead
• Fudan University: collaborator

Study Sites (1)

PET Center, Huashan Hospital, Fudan University

Shanghai, 200235, China

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Liver Neoplasms; Hypoxia

Interventions

fluoromisonidazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Hui Guan, MD

  PET Center, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PET Center, Huashan Hospital, Fudan University, Shanghai, China 200235

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: October 1, 2010
• Study Start: June 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

CN (1)