Non-small cell lung cancer. MedDRA version: 16.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Hyperpolarized Xenon gas
Product Code: HypXe
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Hyperpolarized xenon
Current Sponsor code: HypXe
Other descriptive
Sponsors
Oxford University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are: - • To demonstrate that hyperpolarized Xe-129 is sensitive to change at other time points from two weeks after commencement of radiotherapy schedules to one year following completion of radiotherapy. • To obtain preliminary data demonstrating if baseline hyperpolarized Xe-129 MR imaging is a more reliable clinical indicator of patient respiratory tolerance for NSCLC radical radiotherapy than conventional lung function testing by determining the relationship between MR imaging indices and functional patient outcome measures (exercise ability, dyspnoea and radiation-induced lung toxicity assessment). • To obtain preliminary data demonstrating if changes in hyperpolarized Xe-129 MR imaging objectively and quantifiably assess lung function (ventilation and perfusion) responses following NSCLC radiotherapy. • To use functional lung information in virtual predictive and adaptive radiotherapy treatment planning. ;Main Objective: • To demonstrate that hyperpolarized Xe-129 is sensitive to change at 3 months following radiotherapy, and thus may be developed as an objective and quantifiable method of functional lung assessment in patients with NSCLC undergoing radiotherapy.;Primary end point(s): The primary endpoint is change in ventilation and ADC maps using hyperpolarized Xe-129 MR imaging from baseline to 3 months post radiotherapy.;Timepoint(s) of evaluation of this end point: The time point for evaluation of this end point is 3 months after starting radiotherapy treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints • Change in ventilation and ADC maps using hyperpolarized Xe-129 MR imaging from baseline to other time points post radiotherapy initiation. • Change in lung perfusion and other lung MR imaging parameters from baseline to other time points post radiotherapy initiation. • Correlation between change in ventilation/ ADC maps using hyperpolarized Xe-129 MR imaging and change in lung function from baseline to each time point. • Demonstration of superior correlation of functional patient outcome measures (dyspnoea, quality of life and exercise ability) with ventilation and ADC maps than with lung function. • Comparison of hyperpolarized Xe-129 MR imaging and four-dimensional CT (4D-CT) at baseline. 4D-CT is performed in by the treating Oncologist in the Radiotherapy department for RT planning purposes. The scan is part of routine care and not a study measure, although data will be analysed from this scan to achieve this endpoint. Exploratory Endpoints • Retrospective comparison of modified radiotherapy treatment planning incorporating functional lung information from hyperpolarized Xe-129 MR imaging with conventional radiotherapy treatment plans. ;Timepoint(s) of evaluation of this end point: The time points for evaluation of secondary end points are two weeks after commencement of radiotherapy, on the final day of treatment, 3 months, 6 months and 1 year after treatment initiation. | — |
Countries
United Kingdom
Contacts
Public ContactProgramme Director
Oxford Biomedical Research Centre
Outcome results
None listed