Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789773
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor Device: Millimeter-Wave Holographic Imaging Not Applicable

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Holographic Mm-wave Imaging in Radiation Oncology
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : December 14, 2020
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Diagnostic (holographic mm-wave imaging)
Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial CT simulation.
 Device: Millimeter-Wave Holographic Imaging
Undergo mm-wave holographic imaging
Other Name: Holographic Millimeter-wave Imaging; Holographic mm-Wave Imaging; MMW Holographic Imaging; Millimeter-wave Imaging; MMW Imaging; MMW


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Qualitative assessment of holographic image quality [ Time Frame: Up to 1 year ]
    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.


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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789773


Locations
Layout table for location information
United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Michael Reilly, PhD    708-951-1100    Michael.reilly@med.usc.edu   
Principal Investigator: Michael Reilly, PhD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Michael Reilly University of Southern California
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03789773     History of Changes
Other Study ID Numbers: 0S-18-6
NCI-2018-02994 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
0S-18-6 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No