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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL105643-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other special types of MRI such as conventional proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate goal is to predict the degree of radiation-induced lung injury that will develop in a given patient for a given treatment plan. The investigators anticipate that these images will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. Investigational means that these tests have not yet been approved by the US Food and Drug Administration and are only available in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring changes due to thoracic radiation therapy, therefore, its use in this study is also considered investigational.
Healthy volunteers are being asked to participate in this study because to develop a database of functional images that are representative of healthy lungs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients scheduled to undergo Radiation Therapy (RT) | Active Comparator | Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity. |
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| Healthy volunteers | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperpolarized 129-Xenon gas | Drug | Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP) | "Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%. | Baseline, following radiation treatment (up to 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment) | "Gas exchange" is defined as the ratio of the signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the local 129Xe airspace signal. In other publications, the investigators have referred to this as "RBC (red blood cell) transfer". A "Gas Exchange Defect" is defined as any region of lung where the Gas Exchange signal is more than 2 standard deviations below the mean Gas Exchange signal of healthy volunteer subjects' lungs. "Gas Exchange Defect Percentage", or EDP, is defined as the volume of a subject's Gas Exchange Defects divided by the volume of the subject's lung, multiplied by 100%. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perfusion Defect Percentage (PDP) Following RT | Baseline, following RT (up to 3 months) |
Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
Inclusion/Exclusion Criteria for Healthy Volunteers
1. Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Mammarappallil, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27713 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Scheduled to Undergo Radiation Therapy (RT) | Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity. Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. |
| FG001 | Healthy Volunteers | Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Scheduled to Undergo Radiation Therapy (RT) | Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity. Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pulmonary Function, as Measured by Ventilation Defect Percentage (VDP) | "Ventilation" is defined as the regional 129Xe airspace signal divided by the top 1% of 129Xe airspace signal (representing open-airway ventilation). A "Ventilation Defect" is defined as any region of lung where the Ventilation signal is more than 2 standard deviations below the mean Ventilation signal of healthy volunteer subjects' lungs. "Ventilation Defect Percentage", or VDP, is defined as the volume of a subject's Ventilation Defects divided by the volume of the subject's lung, multiplied by 100%. | Subjects that completed visit 1 and visit 2 (n=10) were analyzed. Not applicable to the healthy volunteers group. | Posted | Mean | Standard Error | Ventilation Defect Percentage (VDP) | Baseline, following radiation treatment (up to 3 months) |
|
Up to 24 hours after Xenon MRI
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Scheduled to Undergo Radiation Therapy (RT) | Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity. Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bastiaan Driehuys, PhD (Professor of Radiology) | Duke University | 919 684-7786 | bastiaan.driehuys@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2018 | Dec 2, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2021 | Dec 2, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| MRI | Device | Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. |
|
| Baseline, following RT (up to 3 months) |
| RBC (Red Blood Cell) to Barrier Ratio Following RT | "RBC:barrier ratio" is defined as the ratio of the whole lung signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the whole lung signal from 129Xe in the alveolar barrier tissue. | Baseline, following RT (up to 3 months) |
| Change in High Barrier Uptake Percentage (HBUP) Following RT | "Barrier Uptake" is defined as the ratio of the regional signal from 129Xe dissolved in the interstitial space within the alveolar walls to the regional signal from 129Xe in the adjacent airspaces. "High Barrier Uptake" is defined as any region of lung where the Barrier Uptake signal is more than 2 standard deviations above the mean Barrier Uptake signal of healthy volunteer subjects' lungs. "High Barrier Uptake Percentage", or HBUP, is defined as the volume of a subject's lung exhibiting High Barrier Uptake divided by the total volume of the subject's lung, multiplied by 100%. | Baseline, following RT (up to 3 months) |
| BG001 | Healthy Volunteers | Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients scheduled to undergo Radiation Therapy (RT) for lung cancer, or other malignancies such as breast cancer or lymphoma that involve significant irradiation of the thoracic cavity.
Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
| OG001 | Healthy Volunteers | Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. |
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|
|
| Secondary | Change in Gas Exchange Defect Percentage (EDP) Following RT (Radiation Treatment) | "Gas exchange" is defined as the ratio of the signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the local 129Xe airspace signal. In other publications, the investigators have referred to this as "RBC (red blood cell) transfer". A "Gas Exchange Defect" is defined as any region of lung where the Gas Exchange signal is more than 2 standard deviations below the mean Gas Exchange signal of healthy volunteer subjects' lungs. "Gas Exchange Defect Percentage", or EDP, is defined as the volume of a subject's Gas Exchange Defects divided by the volume of the subject's lung, multiplied by 100%. | Subjects that competed visit 1 and visit 2 (n=10) were analyzed. Not applicable to the healthy volunteers group. | Posted | Mean | Standard Error | Gas Exchange Defect Percentage (EDP) | Baseline, following RT (up to 3 months) |
|
|
|
| Secondary | RBC (Red Blood Cell) to Barrier Ratio Following RT | "RBC:barrier ratio" is defined as the ratio of the whole lung signal from 129Xe transiently bonding with hemoglobin in the pulmonary capillaries to the whole lung signal from 129Xe in the alveolar barrier tissue. | Subjects that competed visit 1 and visit 2 (n=10) were analyzed. Not applicable to the healthy volunteers group. | Posted | Mean | Standard Error | Ratio | Baseline, following RT (up to 3 months) |
|
|
|
| Secondary | Change in High Barrier Uptake Percentage (HBUP) Following RT | "Barrier Uptake" is defined as the ratio of the regional signal from 129Xe dissolved in the interstitial space within the alveolar walls to the regional signal from 129Xe in the adjacent airspaces. "High Barrier Uptake" is defined as any region of lung where the Barrier Uptake signal is more than 2 standard deviations above the mean Barrier Uptake signal of healthy volunteer subjects' lungs. "High Barrier Uptake Percentage", or HBUP, is defined as the volume of a subject's lung exhibiting High Barrier Uptake divided by the total volume of the subject's lung, multiplied by 100%. | Subjects that competed visit 1 and visit 2 (n=10) were analyzed. Not applicable to the healthy volunteers group. | Posted | Mean | Standard Error | Interstitial space to alveolar walls (%) | Baseline, following RT (up to 3 months) |
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| Other Pre-specified | Change in Perfusion Defect Percentage (PDP) Following RT | Not Posted | Baseline, following RT (up to 3 months) | Participants |
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Healthy Volunteers | Hyperpolarized 129-Xenon gas: Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed. MRI: Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion. | 0 | 8 | 0 | 8 | 0 | 8 |
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