Head and Neck CancerPhase 1/2NCT01213030
Clinical Evaluation of the New Hypoxia Imaging Agent HX4
A Phase 1/2 study testing [F-18] FMISO and [F-18] HX4 in people with Head and Neck Cancer and Lung Cancer, run by Siemens Molecular Imaging at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer, Liver Cancer
- What is being tested?
- [F-18] FMISO and [F-18] HX4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Head and Neck Cancer, Lung Cancer, Liver Cancer
- Being tested
- [F-18] FMISO, [F-18] HX4
- Keywords
- HX4, [F-18]HX4, FMISO, [F-18]FMISO, Solitary Tumor, Hypoxia
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Liver Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18] FMISODrug
10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence
[F-18] HX4Drug
10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence
| Study group | Role | What they receive |
|---|---|---|
| 10 mCi HX4 | Active comparator | Patient will be injected with [F-18] FMISO Receives: Drug: [F-18] HX4 |
| 10 mCi FMISO | Active comparator | Patient will be injected with [F-18] HX4 Receives: Drug: [F-18] FMISO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer)
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Molecular Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Yi Hui Guan, Fudan University
- Investigators
- Yi Hui Guan, MD, Principal investigator, PET Center, Huashan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213030
- Sponsor's protocol ID
- HX4-FMISO
- Status last verified
- Sep 2012
- First submitted
- 14 Aug 2009
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the New Hypoxia Imaging Agent HX4
- ClinicalTrials.gov ID
- NCT01213030
- Acronym / sponsor ID
- HX4-FMISO
- Conditions
- Head and Neck Cancer, Lung Cancer, Liver Cancer
- Keywords
- HX4, [F-18]HX4, FMISO, [F-18]FMISO, Solitary Tumor, Hypoxia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Siemens Molecular ImagingIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 1 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mCi HX4 | Active comparator | Drug: [F-18] HX4Patient will be injected with [F-18] FMISO |
| 10 mCi FMISO | Active comparator | Drug: [F-18] FMISOPatient will be injected with [F-18] HX4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18] FMISO10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence | Drug | 10 mCi FMISO |
| [F-18] HX410 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence | Drug | 10 mCi HX4 |
Primary outcome
Efficacy of a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer)
Time frame: 6 months
1 secondary outcome
Resolution, signal to background ratio, and tumor/blood ratio of PET images with [F-18] FMISO and [F-18]HX4
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Hui Guan, MD principal investigator
PET Center, Huashan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [F-18] FMISO and [F-18] HX4 in people with Head and Neck Cancer and Lung Cancer, run by Siemens Molecular Imaging at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of a hypoxia imaging agent, HX4, in patients with solitary tumors (i.e., locally advanced head and neck cancer) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2012.