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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-10 | Other Identifier | CCRRC | |
| JT 1153 | Other Identifier | JeffTrial Number |
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Administratively Terminated by PI
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To evaluate the use of cone beam computed tomography in treating head and neck to hopefully reduce side effects
The general purpose of this study is to evaluate Kilovoltage (kv) Imaging, specifically the Cone-beam CT (CBCT) scan device, to assess the accuracy of radiation therapy treatment delivery for patients with head and neck neoplasms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cone Beam CT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTV Reduction | Device | The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Interfraction Shift of Patients Undergoing Radiotherapy | Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken. | Daily prior to radiation |
| Average Residual Error Motion of Patients Undergoing Radiotherapy | To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms | Daily after each radiotherapy treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pramila Rani Anne, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19540071 | Result | Den RB, Doemer A, Kubicek G, Bednarz G, Galvin JM, Keane WM, Xiao Y, Machtay M. Daily image guidance with cone-beam computed tomography for head-and-neck cancer intensity-modulated radiotherapy: a prospective study. Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1353-9. doi: 10.1016/j.ijrobp.2009.03.059. Epub 2009 Jun 18. |
| Label | URL |
|---|---|
| Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cone Beam CT | Undergo a cone beam CT scan |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cone Beam CT | Undergo a cone beam CT scan |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Average Interfraction Shift of Patients Undergoing Radiotherapy | Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken. | Posted | Mean | Standard Deviation | millimeters | Daily prior to radiation |
|
|
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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 | Cone Beam CT | Undergo a cone beam CT scan |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucositis | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pramila Rani Anne, MD | Thomas Jefferson University | 215-955-6702 | Pramila.Anne@jefferson.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Average Residual Error Motion of Patients Undergoing Radiotherapy | To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms | Posted | Mean | Standard Deviation | millimeters | Daily after each radiotherapy treatment |
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|
| 1 |
| 30 |
| 7 |
| 30 |
| Dehydration | General disorders |
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| Fever | General disorders |
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| Fatigue | General disorders |
|
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