Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]HX4 diagnostic PET/CT scan | Other | Single intravenous injection of [18F]HX4 and PET/CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with primary treatment failure, tumour recurrence, disease free survival in the first two years after radiotherapy | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of outcome data to determine number of participants with tumour recurrence or disease free survival 5 years after radiotherapy treatment. | 5 years | |
| Comparison of measurements of tumour/nodal disease areas on pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images |
Not provided
Inclusion Criteria:
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.
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
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan C Perkins, PhD | Nottingham University Hospitals NHS Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 5 years |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |