Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEReal-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.
Sponsors
Abramson Cancer Center at Penn Medicine
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects 18 and older * Subjects must be able to read and understand English * Participants must sign the informed consent form
Exclusion criteria
Any subjects not meeting the above inclusion criteria will not be considered for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients | One-time session, up to 4 hours on a single day. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRodney Wiersma, PhD
University of Pennsylvania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Healthy Volunteers |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: One-time session, up to 4 hours on a single day.
Population: 18 healthy volunteers, who successfully completed simulating in a clinical environment but without delivering radiation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Volunteers | Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients | 95 % of time within tolerance |