A study to determine regional lung function in patients with Non-small cell lung cancer (NSCLC) undegoing radiotherapy using hyperpolarised xenon gas MR imaging - Hyperpolarized xenon gas MR imaging in NSCLC Radiotherapy

Oxford University Hospitals NHS Trust0 个研究点开始时间: 2014年2月4日最近更新: 2014年2月10日

适应症

试验速览

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•Study participants with any stage NSCLC considered suitable for radical radiotherapy (with either conventionally fractionated treatment or with stereotactic body radiotherapy (SABR)) or chemoradiotherapy (concurrent or sequential schedule) will be recruited.
•Inclusion Criteria
•Participant is willing and able to give informed consent for participation in the study.
•Male or Female, aged 18 years or above.
•Histologically verified NSCLC.
•Patients with any stage NSCLC where radical radiotherapy (with either conventionally fractionated treatment or with stereotactic body radiotherapy (SABR)) or chemoradiotherapy (concurrent or sequential schedule) is considered appropriate.
•WHO performance status 0-2
•Able (in the Investigators opinion) and willing to comply with all study requirements.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Exclusion Criteria
•The participant may not enter the study if ANY of the following apply:
•Inability to give written informed consent.
•Female participants who are pregnant, lactating or planning pregnancy
•during the course of the trial
•Previous radiotherapy to the chest.
•The presence of another condition where the disease itself or treatment may interfere with the study endpoints.
•Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
•Inability to lie flat for imaging.
•Contraindications to MRI examination including indwelling pacemaker, non-MRI compatible metallic implant, severe claustrophobia, intra-ocular foreign body.
•Contraindications for gadolinium enhanced lung MRI scan – known hypersensitivity/allergy to the injection of MultiHance (contains gadobenate dimeglumine and small quantities of benzyl alcohol) that is given as part of this scanning or an adverse reaction to an injection given during previous MRI scanning, severe renal impairment.
•Contraindications for ventilation/perfusion nuclear medicine scanning – known hypersensitivity to albumin or preference to avoid blood donation product.
•Epilepsy requiring on-going medical treatment, or a seizure within the past year.

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