ung imaging using hyperpolarized xenon gas MR imaging in patients with lung cancer after radiotherapy

• Conditions: on-small cell lung cancer.; MedDRA version: 16.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-002028-41-GB
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified