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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Radiation treatment for each patient with cancer is designed based on CT scans. We know that tumors in the chest and abdomen move when you breathe. Because of this, there can be differences between planned treatment and the treatment actually delivered to the body. Usually with radiation a safety margin is added to ensure that radiation hits the entire tumor. This can damage healthy parts of the body because the exact location of the tumor is unknown.
Magnetic resonance imaging (MRI) is a painless and safe diagnostic procedure that uses a powerful magnet and radio waves to produce detailed images of the body's organs and structures, without the use of X-rays or other radiation.
The research doctors are studying to see if the position of a tumor can be tracked using MRI scans and tracking sensors placed on the skin. MRI scans and the tracking system used to calculate the location and position of the tumor are both FDA approved technologies.
The research doctors will also use the MRI scans to evaluate any changes in your lung function during and following your radiation treatments.
In this study the participant will undergo a series of MRI scans with and without contrast dye.
This study is being funded through grants from the National Institutes of Health (NIH).
In this protocol, we seek to assess whether tumor motion can be inferred using dynamic MRI and external surrogates. We propose to (1) investigate the feasibility of tracking the real-time tumor position using dynamic MRI and inferring tumor position using external surrogates placed on the skin of the subject and (2) determine lung function during and following radiation by assessing lung perfusion maps obtained via dynamic MRI with dose maps in order to determine image-based biomarkers for lung toxicity following radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | This is a pilot study and there is only one group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors | Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm. The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation | The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients must be undergoing radiation therapy with or without chemotherapy for thoracic and/or abdominal cancers.
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| Name | Affiliation | Role |
|---|---|---|
| Warren D. D'Souza, PhD | UMMC MSGCC Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ummc Msgcc | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dynamic Lung MRI | Lung Tumor Motion and Function |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dynmaic Lung MRI | Lung Tumor Motion and Function |
| 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, Categorical | Count of Participants |
| 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 | Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors | Tumor tracking using cine-MRI and external surrogates with an accuracy of ~ 2mm. The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI. | Posted | Number | participants | 2 years |
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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 | Dynamic Lung MRI | Lung Tumor Motion and Function |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Warren D'Souza, PhD, MBA | Universtity of Maryland School of Medicine | 410-328-7159 | wdsouza@umm.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation | The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images. | Posted | Number | participants | 2 years |
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| 0 |
| 16 |
| 0 |
| 16 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |