Brain and Nervous System, Head and Neck Cancer, Intracranial Neoplasm
Conditions
Brief summary
This pilot clinical trial studies how well head and neck maskless immobilization device works in immobilizing patients with head and neck cancers or intracranial tumors undergoing radiation therapy. Maskless immobilization device may help to prevent movement of head during radiation therapy and immobilize patients with the same accuracy and reliability as the standard thermoplastic mask routinely used for patients receiving radiation therapy.
Detailed description
PRIMARY OBJECTIVES: I. To assess the setup accuracy and reproducibility of the maskless immobilization device (MID) in patients being treated for head and neck cancers or intracranial tumors who require radiation therapy SECONDARY OBJECTIVES: I. To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.
Interventions
PROCEDUREComputed Tomography
Undergo CT simulation
DEVICEMedical Device
Given thermoplastic mask
PROCEDURECone-Beam Computed Tomography
Undergo CBCT imaging
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients being treated for head and neck cancers who require radiation therapy or intracranial tumors, over a 2 to 7 week period of time * Age ≥ 18 years old * Subjects are capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf * Provide signed and dated informed consent form
Exclusion criteria
* History of prior trauma or orthopedic surgery to the cervical vertebral column/spine, which may interfere with the RT planning process * Patient requires a neck brace for medical reasons * Skull or bony defect in the area contacting the immobilization straps * RT delivered by clinical setup only (no CT simulation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph | Baseline to Day 15, an average of 31 days | The primary endpoints are to assess the setup accuracy and reproducibility with the Maskless Immobilization Device. Accuracy will be measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph (DRR). The magnitude of shifts will be compared to the shifts required using the gold standard thermoplastic mask. Translational shifts is defined as measuring the shifts in cm between the daily setup and the planning setup. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supportive care (MID) Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15.
Computed Tomography: Undergo CT simulation
Medical Device: Given thermoplastic mask
Medical Device: Given MID
Cone-Beam Computed Tomography: Undergo CBCT imaging | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Supportive care (MID) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized White | 11 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
Primary
Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph
The primary endpoints are to assess the setup accuracy and reproducibility with the Maskless Immobilization Device. Accuracy will be measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph (DRR). The magnitude of shifts will be compared to the shifts required using the gold standard thermoplastic mask. Translational shifts is defined as measuring the shifts in cm between the daily setup and the planning setup.
Time frame: Baseline to Day 15, an average of 31 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Supportive care (MID) | Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph | Vertical | 0.08 centimeters (cm) | Standard Deviation 0.3 |
| Supportive care (MID) | Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph | Longitudinal | 0.16 centimeters (cm) | Standard Deviation 0.52 |
| Supportive care (MID) | Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph | Lateral | -0.02 centimeters (cm) | Standard Deviation 0.47 |