Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03632369
Status:
WITHDRAWN
Last Update Posted:
2023-04-25
First Post:
2018-06-21
Brief Title:
Hyperpolarized Noble Gas MRI Detection of Radiation-Induced Lung Injury
Sponsor:
Thunder Bay Regional Health Research Institute
Organization:
Thunder Bay Regional Health Research Institute
Study Overview
Official Title:
Hyperpolarized Noble Gas MRI Detection of Radiation-Induced Lung Injury
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants were enrolled and no data was collected for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lung cancer is the leading cause of cancer death in the world each year lung cancer claims over 20 000 lives in Canada and more than one million lives globally 1 Significant improvements have been made in treating many other types of cancer but lung cancer care has not realized similar successes Seventy percent of cancers are at an advanced stage at diagnosis and radiation plays a standard role as a part of both radical and palliative therapy in these cases Normal lung tissue is highly sensitive to radiation This sensitivity poses a serious problem it can cause radiation pneumonitis or fibrosis RILI which may result in serious disability and sometimes death Thirty-seven percent of thoracic cancer patients treated with radiation develop RILI in 20 of radiation therapy cases injury to the lungs is moderate to severe 2 In addition radiation-induced pneumonitis that produces symptoms occurs in 5-50 of individuals given radiotherapy for lung cancer 3 4
The chances of clinical radiation pneumonitis are directly related to the irradiated volume of lung 5 However radiation planning currently assumes that all parts of the lung are equally functional Identification of the areas of the lung that are more functional would be beneficial in order to prioritize those areas for sparing during radiation planning In order to limit the amount of RILI to preserve lung function in patients clinicians plan radiation treatment using conformal or intensity-modulated radiotherapy IMRT This makes use of computed tomography CT scans which take into account anatomic locations of both disease and lung but cannot assess the functionality of the lung itself An important component of the rationale of IMRT is that if doses of radiation entering functional tissue are constrained radiation dose can be focused on tumours to spare functional tissues from injury to preserve existing lung function 6 Therefore to optimally reduce toxicity IMRT would depend on data of not only tumour location but also regional lung function
Pulmonary function tests PFTs can detect a decrease in pulmonary function due to the presence of tumours or RILI but because the measurements are performed at the mouth PFTs do not provide regional information on lung function Positron emission tomography PET imaging may be used for radiation planning but PET is limited in its ability to delineate functional tissue it requires administration of a radiopharmaceutical agent it is a slow modality and because it requires use of a cyclotron it is expensive Single-photon emission computed tomography SPECT imaging to measure pulmonary perfusion as a means for delineating functional tissue has been explored 7-11 Whereas SPECT can detect non-functional tissue it offers spatial resolution that is only half that of CT or PET and it does not possess the anatomical resolution necessary for optimal use with IMRT Furthermore like PET SPECT is a slow modality Given the limitations of existing imaging modalities there is an urgent unmet medical need for an imaging modality that can provide complimentary data on regional lung function quickly and non-invasively and that will limit tissue toxicity in radiotherapy for non-small cell lung cancer NSCLC
Hyperpolarized HP gas magnetic resonance imaging MRI has the potential to fill this unmet need HP gas MRI uses HP xenon-129 129Xe to provide non-invasive high resolution imaging without the need for ionizing radiation paramagnetic or iodinated chemical contrast agents HP gas MRI offers the tremendous advantages of quickly providing high-resolution information on the lungs that is noninvasive direct functional and regional Conventional MRI typically detects the hydrogen 1H nucleus which presents limitations for lung imaging due to lack of water molecules in the lungs HP gas MRI detects 129Xe nuclei which are polarized using spin-exchange optical pumping SEOP technique to increase their effective MR signal intensity by approximately 100000 times HP gas MRI has already been widely successful for pulmonary imaging providing high-resolution imaging information on lung structure ventilation function and air-exchange function The technology has proven useful for imaging asthma chronic obstructive pulmonary disease COPD and cystic fibrosis and for assessing the efficacy of therapeutics for these diseases 12 -21 In this project the investigators propose to develop an imaging technology for delineating regions of the lung in humans that are non-functional versus those that are viable using hyperpolarized HP xenon-129 129Xe magnetic resonance imaging MRI will better inform beam-planning strategies in an attempt to reduce RILI in lung cancer patients
The chances of clinical radiation pneumonitis are directly related to the irradiated volume of lung 5 However radiation planning currently assumes that all parts of the lung are equally functional Identification of the areas of the lung that are more functional would be beneficial in order to prioritize those areas for sparing during radiation planning In order to limit the amount of RILI to preserve lung function in patients clinicians plan radiation treatment using conformal or intensity-modulated radiotherapy IMRT This makes use of computed tomography CT scans which take into account anatomic locations of both disease and lung but cannot assess the functionality of the lung itself An important component of the rationale of IMRT is that if doses of radiation entering functional tissue are constrained radiation dose can be focused on tumours to spare functional tissues from injury to preserve existing lung function 6 Therefore to optimally reduce toxicity IMRT would depend on data of not only tumour location but also regional lung function
Pulmonary function tests PFTs can detect a decrease in pulmonary function due to the presence of tumours or RILI but because the measurements are performed at the mouth PFTs do not provide regional information on lung function Positron emission tomography PET imaging may be used for radiation planning but PET is limited in its ability to delineate functional tissue it requires administration of a radiopharmaceutical agent it is a slow modality and because it requires use of a cyclotron it is expensive Single-photon emission computed tomography SPECT imaging to measure pulmonary perfusion as a means for delineating functional tissue has been explored 7-11 Whereas SPECT can detect non-functional tissue it offers spatial resolution that is only half that of CT or PET and it does not possess the anatomical resolution necessary for optimal use with IMRT Furthermore like PET SPECT is a slow modality Given the limitations of existing imaging modalities there is an urgent unmet medical need for an imaging modality that can provide complimentary data on regional lung function quickly and non-invasively and that will limit tissue toxicity in radiotherapy for non-small cell lung cancer NSCLC
Hyperpolarized HP gas magnetic resonance imaging MRI has the potential to fill this unmet need HP gas MRI uses HP xenon-129 129Xe to provide non-invasive high resolution imaging without the need for ionizing radiation paramagnetic or iodinated chemical contrast agents HP gas MRI offers the tremendous advantages of quickly providing high-resolution information on the lungs that is noninvasive direct functional and regional Conventional MRI typically detects the hydrogen 1H nucleus which presents limitations for lung imaging due to lack of water molecules in the lungs HP gas MRI detects 129Xe nuclei which are polarized using spin-exchange optical pumping SEOP technique to increase their effective MR signal intensity by approximately 100000 times HP gas MRI has already been widely successful for pulmonary imaging providing high-resolution imaging information on lung structure ventilation function and air-exchange function The technology has proven useful for imaging asthma chronic obstructive pulmonary disease COPD and cystic fibrosis and for assessing the efficacy of therapeutics for these diseases 12 -21 In this project the investigators propose to develop an imaging technology for delineating regions of the lung in humans that are non-functional versus those that are viable using hyperpolarized HP xenon-129 129Xe magnetic resonance imaging MRI will better inform beam-planning strategies in an attempt to reduce RILI in lung cancer patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None