Patients with either: (a) non small cell lung carcinoma, or (b) squamous cell carcinoma of the upper aerodigestive tract Patients with distant metastases will not be included. MedDRA version: 14.1 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts a
Conditions
Interventions
Product Name: [18F]HX4
Product Code: N/A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [18F]HX4
CAS Number: N/A
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with: (a) 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 (b) squamous cell carcinoma of the upper aerodigestive tract (excluding oesophagus) 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. • Have adequate renal function, defined by creatinine clearance of >30 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 to be notified of participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • 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. • 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. • Patient is a prisoner. • Previous cancer diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do the scan results from the hypoxia imaging (HX4 PET/CT) predict patient outcome two years after treatment?; Secondary Objective: Do the scan results from the hypoxia imaging (HX4 PET/CT) predict patient outcome five years after treatment? Do the scan results from the hypoxia imaging (HX4 PET/CT) give a different indication of patient outcome than the routinely used radiotracer fluorodeoxyglucose (FDG)? FDG is a radiotracer that shows how the body processes sugar, but does not show how the body uses oxygen. Does the tumour size correlate with the intensity of HX4 uptake? ; Primary end point(s): The primary endpoint will be data collection to determine the number of participants with: (a) primary treatment failure (b) tumour recurrence (c) disease free survival in the first two years after radiotherapy treatment, as assessed in routine clinical and imaging follow-up appointments. Distribution of participants into these groups will be analysed in relation to the [18F]HX4 PET/CT scan results. ;Timepoint(s) of evaluation of this end point: Patient outcome data will be gathered for two years after completion of radiotherapy treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be: (i) Collection of outcome data to determine number of participants with: (a) tumour recurrence (b) disease free survival up to five years after radiotherapy treatment. The distribution of participants in these groups will be assessed in relation to the [18F]HX4 PET/CT scan results. (ii) Comparison of pre-treatment [18F]FDG PET/CT images with [18F]HX4 PET/CT images (obtained within a month of each other) in relation to the outcome data, to determine if there is extra value in [18F]HX4 imaging over [18F]FDG imaging for predicting patient outcome. (iii) Comparison of primary tumour and nodal disease site sizes (from pre-treatment contrast enhanced CT or MRI, where available) with the [18F]HX4 intensity in the corresponding areas. ; Timepoint(s) of evaluation of this end point: Patient outcome data will be collected for five years after radiotherapy treatment. | — |
Countries
United Kingdom
Contacts
Public ContactHelen Betts
Nottingham University Hospitals NHS Trust
Outcome results
None listed