Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02151604 |
Other study ID # |
HPX-2011-003 |
Secondary ID |
2011-002028-41 |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
April 23, 2014 |
Est. completion date |
December 31, 2020 |
Study information
Verified date |
September 2021 |
Source |
Oxford University Hospitals NHS Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Survival rates for lung cancer are poor. One year survival rate in the United Kingdon for
males is 27% and for females 30%, falling to less than 10% at five years. Prognosis for lung
cancer is so poor because over two thirds of patients are diagnosed at a late stage when
curative treatment is not possible. Early diagnosis and assessment of tolerance for curative
treatment would make a significant difference to survival rates.
Histologically, approximately 80% of lung cancer is nonsmall cell lung cancer (NSCLC). The
main curative treatment for NSCLC is surgery. Radical radiotherapy and chemoradiotherapy are
other potentially curative treatments. These are suitable for patients who present with
localized tumours that are surgically unresectable due to involvement of critical local
structures or medically inoperable disease due to advanced age or comorbidities. Radiotherapy
aims to deliver a high tumouricidal dose to the tumour without damaging the surrounding
normal lung tissue. A high dose of radiotherapy improves local control but incurs a risk of
inducing toxic effects in the normal lung tissue. If radiationinduced lung toxicity could be
better predicted and monitored, radical radiotherapy could be tailored to the individual,
which could also have the benefit of avoiding or reducing radiation dose to functional lung
tissue.
Currently assessment of patients for radiotherapy involves lung function measurements to
provide a clinical indicator as to whether or not the patient would tolerate treatment and
maintain sufficient functioning lung posttreatment to continue with activities of daily
living without significant impairment. The current gold standard for assessment of lung
function is spirometry and gas transfer. Spirometry and gas transfer measure global lung
function but provides no information about the different regions of the lung or regarding the
support 'framework' of the lung, the parenchyma.Changes in lung function as measured by
spirometry or gas transfer do not coherently correlate with symptom severity or reflect a
decline in patient health. This weak relationship is probably because the lung is a complex
regional organ where localized disturbances of a variety of factors including gas flow
(ventilation), blood flow (perfusion) and gas transfer all combine to impair respiratory
function.
To address these issues we aim to use hyperpolarized xenon gas (Xe129) magnetic resonance
imaging (MRI)and computed tomography (CT)to describe detailed regional and structural lung
abnormality in patients with NSCLC. The investigators will correlate this technique with
baseline spirometry and dyspnoea scores to determine if respiratory tolerance of radiotherapy
is better predicted by hyperpolarized Xe129 MR imaging. The investigators will compare
hyperpolarized Xe129 MRI with standard imaging(nuclear medicine scans). The investigators
will also evaluate changes in hyperpolarized Xe129 MR imaging before, during and after
radiotherapy to determine if it provides improved assessment of radiationinduced lung injury.
MRI has advantage of being free from ionizing radiation making it safe and practical for
diseases like lung cancer where repeated followup scans are necessary. MR imaging has an
enhanced speed of image acquisition compared with CT and lung scintigraphy and offers the
potential of dynamic assessment of lungs during respiration. In conventional MRI, the signal
originates principally from the protons in water molecules of tissues. Therefore conventional
MRI has limited use in respiratory disease because the lung has a very low density of
protons, instead being largely composed of air spaces that do not generate MR signal.
Hyperpolarised noble gases can resolve this problem. Xenon (Xe129) is an unreactive or inert
noble gas. It has a nuclear spin of ½ enabling use in MR imaging to generate a signal. Xe129
is hyperpolarized, that is to say that nuclear spin within the atoms is increased.
Hyperpolarization increases the MR signal enabling the Xe129 gas to show up on the MR scan.
In portions of the lung that have good airflow, the hyperpolarized Xe129 gas will show up
more and be seen more quickly. In addition Xe129 readily dissolves in blood where it emits
different MR signal characteristics. This property may be exploited to regionally quantify
both ventilation and perfusion within the lung providing a comprehensive assessment of lung
function. The need for improved functional imaging to identify preexisting lung disease and
predict respiratory tolerance of patients with NSCLC for radiotherapy treatment is clear.
Hyperpolarized Xe129 MR imaging has the potential to inform individual suitability for
radiotherapy schedules better than the investigations used currently. In addition improved
functional imaging is required to monitor treatment response and enable treatment regimes to
be tailored to the individual. Hyperpolarized Xe129 MR imaging offers the potential of
improved detection of radiationinduced lung injury, invaluable to treating patients with
radiation induced injury. It may also provide information that would allow RT to be planned
in such a way as to reduce the risk of patients developing radiationinduced lung toxicity
(RILT).
The need for improved functional imaging to identify preexisting lung disease and predict
respiratory tolerance of patients with NSCLC for radiotherapy treatment is clear.
Hyperpolarized Xe129 MR imaging has the potential to inform individual suitability for
radiotherapy schedules better than the investigations used currently. In addition improved
functional imaging is required to monitor treatment response and enable treatment regimes to
be tailored to the individual. Hyperpolarized Xe129 MR imaging offers the potential of
improved detection of radiationinduced lung injury, invaluable to treating patients with
radiation induced injury. It may also provide information that would allow RT to be planned
in such a way as to reduce the risk of patients developing radiationinduced lung toxicity
(RILT).