[18F]HX4 PET/CT Imaging for Detection of Hypoxia (OXYPET Study) V1
Research type
Research Study
Full title
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)
IRAS ID
132342
Contact name
Alan Perkins
Contact email
Sponsor organisation
Nottingham University Hospitals
Eudract number
2013-003563-58
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The purpose of this study is to investigate a new radiotracer called HX4. Radiotracers are radioactive substances which are used in PET/CT scanning (Positron Emission Tomography/ X-ray Computed Tomography). A radiotracer is injected into a patient’s arm, and then moves around the bloodstream accumulating in particular parts of the body depending on how they process the radiotracer. The radiotracer we are investigating in this study is called HX4, which shows how the body is using oxygen. HX4 builds up in areas of a tumour which are using up oxygen quickly, making the oxygen levels low (hypoxic tumours). The accumulation of HX4 in hypoxic tumours causes them to show up on the HX4 PET/CT scan.
HX4 PET/CT imaging will be investigated at Nottingham University Hospitals NHS Trust, in patients with cancer of head and neck or lung, who are scheduled for radiotherapy. It is important to know if tumours are hypoxic, because hypoxia can cause radiotherapy treatment to be less effective. However, tumours are not usually checked for hypoxia because the most widely available method for measuring oxygen levels involves insertion of needle electrodes to tumour. This technique is unpleasant for the patient and is technically difficult.
The aim of this study is to investigate whether the results of HX4 PET/CT scans acquired before radiotherapy treatment are linked to patient outcome two years after receiving treatment. Follow up data will continue to be collected for five years post-treatment.
It is anticipated that if the HX4 PET/CT scan shows tumour hypoxia, treatment will be less effective and patients will be more likely to have recurrent disease during the follow up period. This study is the first step towards using PET/CT imaging of hypoxia to improve radiotherapy regimes for patients with hypoxic tumours, who are more likely to have recurrent disease.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0377
Date of REC Opinion
25 Oct 2013
REC opinion
Favourable Opinion