Hypoxia PET/CT in Lung Carcinoma. Version 1.0
Research type
Research Study
Full title
Detection of Hypoxia in Non Small Cell Lung Carcinoma with [18F]FAZA-PET and [18F]FMISO-PET
IRAS ID
200248
Contact name
Kirsten Laws
Contact email
Sponsor organisation
NHS Grampian
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Poor oxygenation (hypoxia) of a tumour is a well recognised characteristic that can adversely affect treatment outcomes in Non Small Cell Lung Cancer (NSCLC). It is therefore an attribute that could be exploited to improve outcomes, particularly in NSCLC where outcomes are frequently poor. However, assessment of tumour hypoxia is not currently part of a patients’ standard management. \nHypoxia has been assessed in the research setting with Positron Emission Tomography/Computed Tomography (PET/CT), using radiotracers that specifically localise in hypoxic tumour cells. This technology could allow non-invasive assessment of intratumour oxygen levels, enabling future stratification and targeting of therapies to hypoxic areas. At present, no one tracer has been clinically validated as reproducible and truly representative of the intratumoral environment. Further research is required. \nWe propose a study to assess two leading hypoxia tracers, 18F-Fluoromizonidazole (18F-FMISO) and 18F-Fluoroazomycin arabinoside (18F-FAZA), in NSCLC. Evidence from previous studies has shown areas of hypoxia occur frequently in NSCLC, and are associated with a poorer prognosis. The aim is to provide preliminary information on the potential advantages and limitations of imaging hypoxia with these two tracers in NSCLC patients. The study will compare the use of 18F-FMISO and 18F-FAZA in a small series of NSCLC patients, assessing their reproducibility with time. Patients will undergo a test-retest programme to ascertain if the hypoxia scans are reproducible with time as the only variable. 5 patients will undergo a test-retest with 18F-FAZA PET, with an initial 18F-FAZA scan, followed by a subsequent 18F-FAZA scan at an interval of 2-7 days. A second set of 5 patients will undergo the same process with 18F-FMISO PET. \nThis data will be utilised to design further studies stratifying hypoxia in NSCLC, allowing the optimisation of treatment such as dose escalation studies for radiotherapy, and the development of experimental therapeutics targeting hypoxia.
REC name
North of Scotland Research Ethics Committee 1
REC reference
16/NS/0085
Date of REC Opinion
25 Oct 2016
REC opinion
Further Information Favourable Opinion