Using a Head and Neck Maskless Immobilization Device For Patients With Intracranial Tumors

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.

• Computed Tomography (Procedure), also known as CAT Scan, CAT, Computerized Axial Tomography: Undergo CT simulation
• Medical Device (Device): Given thermoplastic mask
• Medical Device (Device): Given MID
• Cone-Beam Computed Tomography (Procedure): Undergo CBCT imaging

Primary outcomes

• 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.

Sex: All, ages: 18 Years to any

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)

Participant flow

Outcome results

• Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph (Primary), Mean, centimeters (cm): Supportive care (MID) 0.08 +/- 0.30

Adverse events

Time frame: Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation.

Serious adverse events by term

Other adverse events by term

22 more terms not shown.

• Study Protocol and Statistical Analysis Plan (PDF, 2020-02-04)

• Voichita Bar Ad, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University