Hyperpolarized Xenon Gas MR Imaging in NSCLC Radiotherapy

NCT02151604 | Completed Phase 2 Results

• 2 other identifiers: HPX-2011-0032011-002028-41
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the second most commonly diagnosed cancer in the United Kingdom, accounting for 22% of cancer deaths. The main treatments for lung cancer are surgery, radiotherapy or chemoradiotherapy. Current methods, for assessing lung function in lung cancer patients i.e. spirometry and gas transfer are inadequate. We aim to develop a new technique capable of describing regional lung abnormality using hyperpolarized xenon gas MRI. The study will involve 50 patients diagnosed with lung cancer considered suitable for radical radiotherapy or chemoradiotherapy. Participants will be offered hyperpolarized Xe129 MR at baseline, two weeks after commencement of radiotherapy schedules and four followup visits over one year posttreatment. Patients will undertake extensive study measures at baseline and followup visits, including chest CT scans, ventilation/perfusion nuclear medicine scans, gadolinium enhanced MRI scans, pulmonary function tests, breathlessness scores, radiotherapy induced lung toxicity assessments and exercise testing. Participation in these full tests takes a day, allowing patients time to rest between tests and allowing for a period of observation following the final hyperpolarized xenon scan. The investigators will correlate baseline hyperpolarized Xe129 MR imaging with spirometry and breathlessness scores to determine if tolerance for radiotherapy is better predicted by hyperpolarized Xe129 MR imaging. The investigators will evaluate changes in hyperpolarized Xe129 MR imaging before and after radiotherapy (RT) to determine if it provides better monitoring of response compared with spirometry. The study will take place at the Churchill Hospital, Oxford University Hospitals National Health Service Trust and will be funded by the National Institute for Health Research Oxford Biomedical Research Centre. Hyperpolarized Xe129 MR imaging has the potential to inform individual suitability for radiotherapy schedules better than the investigations used currently. In addition, hyperpolarized Xe129 MR imaging has the potential for better monitoring of treatment response and improved detection of radiation induced lung injury, invaluable to treating patients with radiation induced injury.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Change From Baseline in Ventilation Map Using Hyperpolarized Xe-129 MR Imaging

  Number of participants with a change from baseline in ventilation map using hyperpolarized Xe-129

  Mid-point of radiotherapy - varies depending on the duration of treatment prescribed, between 1 week to 2 months from the baseline scan (range: 7 days to 60 days). For example, for 2 weeks of radiotherapy, this would be at 1 week post-baseline.

Secondary Outcomes (2)

• Number of Participants With a Change in Ventilation and ADC Maps Using Hyperpolarized Xe-129 MR Imaging From Baseline to 3 Months Post Radiotherapy Completion

  3 months after completion of treatment

• Correlation Between Change in Ventilation/ ADC Maps Using Hyperpolarized Xe-129 MR Imaging and Change in Lung Function From Baseline to Follow-up (During Treatment)

  Mid-point of radiotherapy - varies depending on the duration of treatment prescribed, between 1 week to 2 months from the baseline scan - Range: 7-60 days.) For example, for 2 weeks of radiotherapy, this would be at 1 week post-baseline.

Study Arms (1)

129 Xenon MR Imaging

EXPERIMENTAL

Xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.

Drug: Inhalation of hyperpolarized xenon gas

Interventions

Inhalation of hyperpolarized xenon gas DRUG

The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.

129 Xenon MR Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial
• 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

You may not qualify if:

• Inability to give written informed consent
• Female participant who is 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, England, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

3 patients were recruited prior a substantial amendment was put in place thus were excluded from the analysis due to different study objectives being in place at that time. 4 patients were not able to breath hold during the MRI scan and therefore good quality image scans of their lungs could not be obtained on those occasions. The scans were excluded from the analysis.

Results Point of Contact

• Title: Avianna Laws, Clinical Research Operations Manager
• Organization: Oxford University Hospitals NHS Foundation Trust

avianna.laws@ouh.nhs.uk

01865 (2)26221

Study Officials

• Fergus V Gleeson, MB BS, FRCP

  Professor of Radiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 30, 2014
• Study Start: April 23, 2014
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 23, 2023
• Results First Posted: February 23, 2023

Record last verified: 2021-09

Locations

GB (1)