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Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Primary Purpose

Head and Neck Cancer, Lung Cancer, Liver Cancer

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

[F-18] FMISO

[F-18] HX4

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring HX4, [F-18]HX4, FMISO, [F-18]FMISO, Solitary Tumor, Hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

PET Center, Huashan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

10 mCi HX4

10 mCi FMISO

Arm Description

Patient will be injected with [F-18] FMISO

Patient will be injected with [F-18] HX4

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Resolution, signal to background ratio, and tumor/blood ratio of PET images with [F-18] FMISO and [F-18]HX4

Full Information

NCT ID

NCT01213030

First Posted

August 14, 2009

Last Updated

September 20, 2012

Sponsor

Siemens Molecular Imaging

Collaborators

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01213030

Brief Title

Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Official Title

Clinical Evaluation of the New Hypoxia Imaging Agent HX4

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Siemens Molecular Imaging

Collaborators

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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-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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer, Lung Cancer, Liver Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 mCi HX4

Arm Type

Active Comparator

Arm Description

Patient will be injected with [F-18] FMISO

Arm Title

10 mCi FMISO

Arm Type

Active Comparator

Arm Description

Patient will be injected with [F-18] HX4

Intervention Type

Drug

Intervention Name(s)

[F-18] FMISO

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

[F-18] HX4

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Resolution, signal to background ratio, and tumor/blood ratio of PET images with [F-18] FMISO and [F-18]HX4

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Hui Guan, MD

Organizational Affiliation

PET Center, Huashan Hospital, Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

PET Center, Huashan Hospital, Fudan University

City

Shanghai

ZIP/Postal Code

200235

Country

China

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of the New Hypoxia Imaging Agent HX4

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