- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789773
Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy
January 30, 2023 updated by: University of Southern California
Holographic Mm-wave Imaging in Radiation Oncology
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (holographic mm-wave imaging)
Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial CT simulation.
|
Undergo mm-wave holographic imaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Reilly, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2022
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
December 27, 2018
First Submitted That Met QC Criteria
December 27, 2018
First Posted (Actual)
December 31, 2018
Study Record Updates
Last Update Posted (Actual)
February 1, 2023
Last Update Submitted That Met QC Criteria
January 30, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 0S-18-6 (Other Identifier: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH Grant/Contract)
- NCI-2018-02994 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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