Head and Neck CancerPhase 2OXYPETNCT02976883
[18F]HX4 PET/CT Imaging for Detection of Hypoxia
A Phase 2 study testing [18F]HX4 diagnostic PET/CT scan in people with Head and Neck Cancer and Lung Cancer, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. 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
- What is being tested?
- [18F]HX4 diagnostic PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Mar 2015to 25 Jul 2017
- Phase
- Phase 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
- Patients with:
- biopsy proven non-small cell carcinoma of the lung >2.5 cm in size with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent or
- squamous cell carcinoma of the upper aerodigestive tract with a primary tumour or nodal mass >2. 5 cm in size, with any T and N status but M0 who have elected to undergo radical radiotherapy or chemo-radiotherapy with curative intent.
- Participant must be willing and able to give informed consent for participation in the study.
- Patients must be 18 years old or above.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
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- Have normal renal function, defined by creatinine clearance of >60 mL/min.
- Able to remain still in the supine position on the scanner bed for the 40 minute duration of the examination.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and hospital consultant, if appropriate, to be notified of participation in the study
Who cannot join
- Patients who are scheduled for surgery prior to radiotherapy will not be included.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Chronic kidney disease stage III or worse, as defined by the NKF clinical practice guidelines (GFR <60 mL/min per 1.73 m3 for 3 months or more).
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of involvement in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who have been involved in another research study involving an investigational product in the past 12 weeks.
- Previous surgery or radiotherapy to the upper aerodigestive tract or lung, which in the opinion of the Investigators could compromise the data.
- Previous cancer diagnosis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: A Phase II, Single Centre Exploratory Study of [18F]HX4 PET/CT Imaging to Detect Hypoxia in Patients With Head and Neck and Lung Cancer, Receiving Radiotherapy With Curative Intent
The aim of this study is to investigate the radiotracer [18F]HX4 for non-invasive detection of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up data will be collected from routine appointments, and analysed with the hypoxia scan results to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy treatment.
- Conditions
- Head and Neck Cancer, Lung Cancer
- Being tested
- [18F]HX4 diagnostic PET/CT scan
- Keywords
- Hypoxia, HX4, PET CT, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]HX4 diagnostic PET/CT scanOther
Single intravenous injection of [18F]HX4 and PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| [18F]HX4 diagnostic PET/CT scan | Experimental | [18F]HX4 (370 MBq) will be administered by a single intravenous injection, after which patients will be required to wait for ≤4.0 h and undergo a PET/CT scan. Receives: Other: [18F]HX4 diagnostic PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy
Measured: 2 years
Secondary outcomes (2)
Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.
Measured: 5 years
Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start31 Mar 2015
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan C Perkins, PhD, Study chair, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976883
- Sponsor's protocol ID
- 13MP003
- Acronym
- OXYPET
- Status last verified
- Jan 2019
- First submitted
- 24 Aug 2016
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Centre Exploratory Study of [18F]HX4 PET/CT Imaging to Detect Hypoxia in Patients With Head and Neck and Lung Cancer, Receiving Radiotherapy With Curative Intent
- ClinicalTrials.gov ID
- NCT02976883
- Acronym / sponsor ID
- OXYPET / 13MP003
- Conditions
- Head and Neck Cancer, Lung Cancer
- Keywords
- Hypoxia, HX4, PET CT, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 31 Mar 2015 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 29 Nov 2016 (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 investigate the radiotracer [18F]HX4 for non-invasive detection of hypoxia in patients with head and neck, or lung cancer. Each participant will undergo a diagnostic [18F]HX4 PET/CT scan before beginning radiotherapy treatment. Patient follow up data will be collected from routine appointments, and analysed with the hypoxia scan results to assess whether [18F]HX4 PET/CT scanning can predict patient outcome from radiotherapy treatment.
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 diagnostic PET/CT scan | Experimental | Other: [18F]HX4 diagnostic PET/CT scan[18F]HX4 (370 MBq) will be administered by a single intravenous injection, after which patients will be required to wait for ≤4.0 h and undergo a PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with:
- Participant must be willing and able to give informed consent for participation in the study.
- Patients must be 18 years old or above.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Have normal renal function, defined by creatinine clearance of >60 mL/min.
Key exclusion criteria (7 listed)
- Patients who are scheduled for surgery prior to radiotherapy will not be included.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Chronic kidney disease stage III or worse, as defined by the NKF clinical practice guidelines (GFR <60 mL/min per 1.73 m3 for 3 months or more).
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of involvement in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who have been involved in another research study involving an investigational product in the past 12 weeks.
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 |
|---|---|---|
| [18F]HX4 diagnostic PET/CT scanSingle intravenous injection of [18F]HX4 and PET/CT scan | Other | [18F]HX4 diagnostic PET/CT scan |
Primary outcome
The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy
Time frame: 2 years
2 secondary outcomes
Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment.
Time frame: 5 years
Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images
Time frame: 5 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 11 Jan 2019.
- 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.
Alan C Perkins, PhD study chair
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]HX4 diagnostic PET/CT scan in people with Head and Neck Cancer and Lung Cancer, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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 7 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 11 Jan 2019. 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 United Kingdom. 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 phase mean?
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?
The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy (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 11 Jan 2019.