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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA227124-02 | U.S. NIH Grant/Contract | View source | |
| 843058 | Other Identifier | University of Pennsylvania Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive and since healthy volunteers are enrolled in this study, no radiation is delivered, but in the future, the investigators plan to use this device during radiation treatment with patients.
This study aims to passively monitor the real-time head motions of healthy volunteers positioned to simulate whole brain radiation therapy. Such real-time head motion data is necessary in order to understand the type (amplitude/frequency) of motion that the robotic stage will be expected to compensate for and will play an important role in the overall modeling and designing process of the robotic prototype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | The volunteer population will consist of healthy individuals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time head stabilization with robotic platform | Device | A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive. |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients | Real-time intracranial target motion was continuously monitored using a commercial surface-guided radiation therapy (SGRT) system operating at approximately 10 frames per second. For each participant, translational (mm) and rotational (degree) motion of the target were computed relative to the starting head position at setup. The target position was tracked in six degrees of freedom (longitudinal, lateral, vertical translation; pitch, roll, yaw rotation). To provide a quantitative endpoint reflecting system effectiveness, the recorded 6D target motion data were analyzed and positional deviation histograms showing the total percentage of time that the target remained below a specific translational and rotational tolerance level were generated. The percentage of time that the target remained below a tolerance of < 1.0 mm translational and < 1.0° rotational deviation was chosen as the single primary outcome measure. | One-time session, up to 4 hours on a single day. |
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Inclusion Criteria:
Exclusion Criteria:
Any subjects not meeting the above inclusion criteria will not be considered for this study.
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The volunteer population will consist of healthy individuals.
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| Name | Affiliation | Role |
|---|---|---|
| Rodney Wiersma, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | The volunteer population will consist of healthy individuals. Real-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | The volunteer population will consist of healthy individuals. Real-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients | Real-time intracranial target motion was continuously monitored using a commercial surface-guided radiation therapy (SGRT) system operating at approximately 10 frames per second. For each participant, translational (mm) and rotational (degree) motion of the target were computed relative to the starting head position at setup. The target position was tracked in six degrees of freedom (longitudinal, lateral, vertical translation; pitch, roll, yaw rotation). To provide a quantitative endpoint reflecting system effectiveness, the recorded 6D target motion data were analyzed and positional deviation histograms showing the total percentage of time that the target remained below a specific translational and rotational tolerance level were generated. The percentage of time that the target remained below a tolerance of < 1.0 mm translational and < 1.0° rotational deviation was chosen as the single primary outcome measure. | 18 healthy volunteers, who successfully completed simulating in a clinical environment but without delivering radiation | Posted | Mean | 95% Confidence Interval | % of time within tolerance | One-time session, up to 4 hours on a single day. |
1 year and 6 months
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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 | Healthy Volunteers | The volunteer population will consist of healthy individuals. Real-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rodney Wiersma, PhD | University of Pennsylvania | 773-623-9820 | Rodney.Wiersma@pennmedicine.upenn.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 | Dec 14, 2022 | Oct 29, 2025 | Prot_SAP_000.pdf |
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| 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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| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Healthy Volunteers | The volunteer population will consist of healthy individuals. Real-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive. |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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