Hypoxia PET/CT Scanning in Patients with Cancer, Who are Receiving Radiotherapy (OXYPET Study)
- Conditions
- 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 and polyps)MedDRA version: 14.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2013-003563-58-GB
- Lead Sponsor
- ottingham University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
•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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method