Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
This trial studies the quality of holographic mm-wave imaging in patients undergoing radiation therapy. Holographic mm-wave imaging is a common type of imaging used in airport body scanners that may be helpful in improving the efficiency and positioning of radiation oncology patients and their overall experience.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To obtain patient images in a clinical setting and assess their quality. SECONDARY OBJECTIVES: I. To assess the registration agreement through a voxel-voxel distance-to-agreement metric. OUTLINE: Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial computed tomography (CT) simulation.

Official Title
-----------------
Holographic Mm-wave Imaging in Radiation Oncology

Conditions
-----------------
Unspecified Adult Solid Tumor

Intervention / Treatment
-----------------
* Device: Millimeter-Wave Holographic Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled to receive either an optical or CBCT imaging scan as part of their treatment management. The study will be open to English and Spanish speaking participants. Exclusion Criteria: Patients that are not scheduled for fluoroscopic or optical imaging as part of the normal course of radiotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (holographic mm-wave imaging)<br>Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial CT simulation. | Device: Millimeter-Wave Holographic Imaging<br>* Undergo mm-wave holographic imaging<br>* Other names: Holographic Millimeter-wave Imaging; Holographic mm-Wave Imaging; MMW Holographic Imaging; Millimeter-wave Imaging; MMW Imaging; MMW;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative assessment of holographic image quality | Qualitative assessment of image quality by study physicians according to the scoring of each image as: 1 = High Quality (A); 2= Acceptable Quality (B); 3 = Poor/Unacceptable Quality (C). Lower value (1) represents a better score than higher value (3). There are no subscales and or total scores. The quality scores of the images will be tabulated. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image registration agreement between mm-wave holographic images and a cone-beam computed tomography (CBCT)/optical surface image | The distribution of the percent of points in voxel-voxel analysis to agree to better than 2 mm will be tabulated | Up to 1 year |