Clinical Trial Results:
A Phase II, single-centre exploratory study to assess the value of hypoxia imaging with [18F]HX4 PET/CT in predicting outcome for patients with squamous cell carcinoma of head and neck and non-small cell lung cancer undergoing radical radiotherapy with curative intent (OXYPET Study)

Trial information Top of page
Trial identification
Sponsor protocol code	PET_HX4_01
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Nottingham University Hospitals NHS Trust
Sponsor organisation address	Queen's Medical Centre, Derby Road, Nottingham, United Kingdom, NG7 2UH
Public contact	Helen Betts, Nottingham University Hospitals NHS Trust, 0044 01159709172, helen.betts2@nuh.nhs.uk
Scientific contact	Helen Betts, Nottingham University Hospitals NHS Trust, 0044 01159709172, helen.betts2@nuh.nhs.uk
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	25 Jul 2017
Is this the analysis of the primary completion data?	Yes
Primary completion date	25 Jul 2017
Global end of trial reached?	Yes
Global end of trial date	25 Jul 2017
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	Do the scan results from the hypoxia imaging (HX4 PET/CT) predict patient outcome two years after treatment?
Protection of trial subjects	Adverse events were monitored up to 72 hours post HX4 administration. No special measures required.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	31 Mar 2015
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	United Kingdom: 3
Worldwide total number of subjects	3
EEA total number of subjects	3
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	2
From 65 to 84 years	1
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	Eight eligible patients consented to take part. Only three out of eight participants had the HX4 PET/CT scan due to scheduling difficulties.
Pre-assignment
Screening details	Patients were screened for eligibility by consultant oncologists at clinic appointments. Interested patients were given the trial information sheet. Consent was signed at the next appointment. In addition to the eight consented patients, two further patients were interested but exclusion criteria applied (low kidney function and too unwell).
Period 1
Period 1 title	Overall trial (overall period)
Is this the baseline period?	Yes
Allocation method	Not applicable
Blinding used	Not blinded
Arms
Arm title	[18F]HX4 PET/CT scan
Arm description	Each participant had a single pre-treatment [18F]HX4 PET/CT scan.
Arm type	Experimental
Investigational medicinal product name	[18F]HX4
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	370 MBq intravenous injection
Number of subjects in period 1 [18F]HX4 PET/CT scan Started 3 Completed 3

Subject disposition Top of page

Baseline characteristics Top of page

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	[18F]HX4 PET/CT scan
Reporting group description	Each participant had a single pre-treatment [18F]HX4 PET/CT scan.

End points Top of page

Primary: Two year patient outcome Top of page
End point title	Two year patient outcome [1]
End point description	Patients to be grouped and analysed with reference to hypoxia status from the HX4 PET/CT scan results.
End point type	Primary
End point timeframe	Two years post radiotherapy treatment.
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Recruitment was closed after only three participants had undergone the [18F]HX4 PET/CT scan, because [18F]HX4 was no longer available to the investigators. Two year follow up was not collected for the three participants. Statistical analysis was not warranted.
End point values [18F]HX4 PET/CT scan Number of subjects analysed 0 [2] Units: number of patients     primary treatment failure     disease free survival     tumour recurrence
Notes [2] - Two year follow up data not collected due to insufficient recruitment.
No statistical analyses for this end point

Primary: Two year patient outcome Top of page

Secondary: Five year outcome Top of page
End point title	Five year outcome
End point description	Assessment of predictive value of the HX4 PET/CT scan on treatment outcome 5 years after radiotherapy treatment.
End point type	Secondary
End point timeframe	Five years post radiotherapy treatment
End point values [18F]HX4 PET/CT scan Number of subjects analysed 0 [3] Units: Patient number     disease free survival     tumour recurrence
Notes [3] - Two and five year follow up data not collected due to insufficient recruitment.
No statistical analyses for this end point

Secondary: Five year outcome Top of page

Secondary: Comparison of [18F]HX4 with [18F]FDG PET/CT for prognostic value Top of page
End point title	Comparison of [18F]HX4 with [18F]FDG PET/CT for prognostic value
End point description	Comparison of pre-treatment [18F]HX4 PET/CT scans with [18F]FDG PET/CT scans in relation to treatment outcome data, to determine if [18F]HX4 PET/CT adds value to [18F]FDG PET/CT imaging for predicting patient outcome.
End point type	Secondary
End point timeframe	Two years and five years post-radiotherapy treatment.
End point values [18F]HX4 PET/CT scan Number of subjects analysed 0 [4] Units: number of patients
Notes [4] - Two and five year follow up data not collected due to insufficient recruitment.
No statistical analyses for this end point

Secondary: Comparison of [18F]HX4 with [18F]FDG PET/CT for prognostic value Top of page

Secondary: Comparison of lesion size with intensity of HX4 uptake Top of page
End point title	Comparison of lesion size with intensity of HX4 uptake
End point description
End point type	Secondary
End point timeframe	No time frame defined.
End point values [18F]HX4 PET/CT scan Number of subjects analysed 0 [5] Units: cm3 and standardised uptake value     number (not applicable)
Notes [5] - Insufficient recruitment to provide conclusions.
No statistical analyses for this end point

Secondary: Comparison of lesion size with intensity of HX4 uptake Top of page

Adverse events Top of page
Adverse events information [1]
Timeframe for reporting adverse events	72 hours post injection of [18F]HX4
Assessment type	Non-systematic
Dictionary used for adverse event reporting
Dictionary name	Not required
Dictionary version	0
Frequency threshold for reporting non-serious adverse events: 0%
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Three participants underwent the [18F]HX4 scan, and no adverse events were encountered. This was in line with expectations from the reference safety information.

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
12 Dec 2013	Addition of urine pregnancy test for female participants of reproductive capacity, prior to [18F]HX4 PET/CT scan.
19 Dec 2013	Submission of updated Investigator Brochure.
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

More information Top of page