Cancer of the Head and NeckNCT01347281
PET With [18F]HX4 in Head and Neck Cancer
A study testing Injection of [18F]HX4 in people with Cancer of the Head and Neck, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with [18F] HX4 PET imaging in head and neck tumors (ii) correlate the [18F] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal timing of [18F] HX4 PET imaging (iv) compare [18F] HX4 PET… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer of the Head and Neck
- What is being tested?
- Injection of [18F]HX4
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2011to Sep 2015
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmed HNSSC of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0
- Tumor diameter ≥ 2,5 cm
- WHO performance status 0 to 2
- Scheduled for primary curative (concurrent chemo-) radiotherapy
- No previous surgery to the head and neck
- No previous radiation to the head and neck
Show all 10Show fewer
- Adequate renal function (calculated creatinine clearance at least 60 ml/min).
- The patient is willing and capable to comply with study procedures
- 18 years or older
- Have given written informed consent before patient registration
Who cannot join
- No recent (< 3 months) myocardial infarction
- No Uncontrolled infectious disease
- Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht Radiation Oncology (MAASTRO clinic)
Maastricht, 6229 ET
About this study
Official title: Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Head and Neck Cancer.
The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with [18F] HX4 PET imaging in head and neck tumors (ii) correlate the [18F] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal timing of [18F] HX4 PET imaging (iv) compare [18F] HX4 PET uptake with [18F] FDG PET uptake before and after treatment.
Read the detailed description
Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In head and neck cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. [18F]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, we expect that [18F]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as [18F]-misonidazole. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.
Included are eligible patients with head and neck squamous cell carcinoma (T2, T3, T4, any N, M0) with tumor diameter ≥ 2,5 cm of the oral cavity, oropharynx, hypopharynx or larynx, planned to be treated with curative primary radiation treatment (+/- concurrent chemotherapy). Before treatment a standard planning [18F]FDG PET-CT will be performed, a blood sample is drawn and baseline [18F]HX4 PET scans will be performed. 18F-HX4 scans will be repeated after radiotherapy treatment with 20 +/- 4 Gy (approximately two weeks). Three months after the end of treatment a [18F]FDG PET scan will be performed.
- Conditions
- Cancer of the Head and Neck
- Being tested
- Injection of [18F]HX4
- Keywords
- Cancer of the Head and Neck, [18F]HX4, hypoxia, PET, phase II trial
- Medical subject headings
- Head and Neck Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of [18F]HX4Procedure or surgery
Injection of [18F]HX4 before treatment (baseline) and after radiotherapy with 20 +/-4 Gy:
[18F]HX4 PET scans; 444 MBq (12 mCi) [18F]HX4 administrated via a bolus IV injection. Image acquisition: static scan at 240 min p.i.
Venous blood sampling: before injection of [18F]HX4 (blood hypoxia markers) Follow-up (3 months after treatment): [18F]FDG PET in treatment position
| Study group | Role | What they receive |
|---|---|---|
| [18F]HX4 PET | Experimental | Injection of [18F]HX4 Receives: Procedure: Injection of [18F]HX4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Measured: 2 years
Secondary outcomes (8)
Observe spatial and temporal stability of [18F] HX4 PET images
Measured: 2 years
Correlation of [18F] HX4 with local tumor recurrence and survivalG PET
Measured: 2 years
Image quality of [18F] HX4-PET at different time points
Measured: 2 years
Kinetic analysis of HX4
Measured: 2 years
Correlation of hypoxia imaging with blood hypoxia markers
Measured: 2 years
Correlation of hypoxia imaging with tumor tissue biomarkers
Measured: 2 years
Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
Measured: 2 years
Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the Head and NeckStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philppe Lambin, Prof. Dr., Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347281
- Sponsor's protocol ID
- 11-12-23/03-intern-6470
- Other IDs
- 2011-001812-80
- Status last verified
- Jan 2017
- First submitted
- 3 May 2011
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Imaging of [18F]HX4 With Positron-Emission-Tomography (PET) in Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT01347281
- Acronym / sponsor ID
- 11-12-23/03-intern-6470
- Conditions
- Cancer of the Head and Neck
- Keywords
- Cancer of the Head and Neck, [18F]HX4, hypoxia, PET, phase II trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 May 2011 (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.
The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with [18F] HX4 PET imaging in head and neck tumors (ii) correlate the [18F] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal timing of [18F] HX4 PET imaging (iv) compare [18F] HX4 PET uptake with [18F] FDG PET uptake before and after treatment.
Detailed description
Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. In head and neck cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. [18F]HX4 is being developed as a diagnostic radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because of the short half life and clearance, we expect that [18F]HX4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as [18F]-misonidazole. The clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.
Included are eligible patients with head and neck squamous cell carcinoma (T2, T3, T4, any N, M0) with tumor diameter ≥ 2,5 cm of the oral cavity, oropharynx, hypopharynx or larynx, planned to be treated with curative primary radiation treatment (+/- concurrent chemotherapy). Before treatment a standard planning [18F]FDG PET-CT will be performed, a blood sample is drawn and baseline [18F]HX4 PET scans will be performed. 18F-HX4 scans will be repeated after radiotherapy treatment with 20 +/- 4 Gy (approximately two weeks). Three months after the end of treatment a [18F]FDG PET scan will be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]HX4 PET | Experimental | Procedure: Injection of [18F]HX4Injection of [18F]HX4 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological or cytological confirmed HNSSC of the oral cavity, oropharynx, hypopharynx, larynx, T2-T3-T4, any N, M0
- Tumor diameter ≥ 2,5 cm
- WHO performance status 0 to 2
- Scheduled for primary curative (concurrent chemo-) radiotherapy
- No previous surgery to the head and neck
Key exclusion criteria (3 listed)
- No recent (< 3 months) myocardial infarction
- No Uncontrolled infectious disease
- Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
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 |
|---|---|---|
| Injection of [18F]HX4Injection of [18F]HX4 before treatment (baseline) and after radiotherapy with 20 +/-4 Gy: [18F]HX4 PET scans; 444 MBq (12 mCi) [18F]HX4 administrated via a bolus IV injection. Image acquisition: static scan at 240 min p.i. Venous blood sampling: before injection of [18F]HX4 (blood hypoxia markers) Follow-up (3 months after treatment): [18F]FDG PET in treatment position | Procedure or surgery | [18F]HX4 PET |
Primary outcome
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
Time frame: 2 years
Visualisation of tumor hypoxia with [18F] HX4 PET imaging
8 secondary outcomes
Observe spatial and temporal stability of [18F] HX4 PET images
Time frame: 2 years
Correlation of [18F] HX4 with local tumor recurrence and survivalG PET
Time frame: 2 years
Image quality of [18F] HX4-PET at different time points
Time frame: 2 years
Kinetic analysis of HX4
Time frame: 2 years
Correlation of hypoxia imaging with blood hypoxia markers
Time frame: 2 years
Correlation of hypoxia imaging with tumor tissue biomarkers
Time frame: 2 years
Spatial correlation of [18F] HX4-PET with [18F] FDG PET pre-treatment
Time frame: 2 years
Spatial correlation of [18F] HX4-PET with [18F] FDG PET three months after treatment
Time frame: 2 years
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 30 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Philppe Lambin, Prof. Dr. principal investigator
Maastro Clinic, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of [18F]HX4 in people with Cancer of the Head and Neck, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 10 inclusion and 3 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 30 Jan 2017. 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 Netherlands. 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.
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?
Visualisation of tumor hypoxia with [18F] HX4 PET imaging (time frame: 2 years). 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 30 Jan 2017.