Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy

NCT03789773 | Withdrawn DMC FDA Device

• 3 other identifiers: 0S-18-6NCI-2018-02994P30CA014089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Image registration agreement between mm-wave holographic images and a cone-beam computed tomography (CBCT)/optical surface image

  Up to 1 year

Study Arms (1)

Diagnostic (holographic mm-wave imaging)

EXPERIMENTAL

Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial CT simulation.

Device: Millimeter-Wave Holographic Imaging

Interventions

Millimeter-Wave Holographic Imaging DEVICE

Undergo mm-wave holographic imaging

Also known as: Holographic Millimeter-wave Imaging; Holographic mm-Wave Imaging; MMW Holographic Imaging; Millimeter-wave Imaging; MMW Imaging; MMW

Diagnostic (holographic mm-wave imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients that are not scheduled for fluoroscopic or optical imaging as part of the normal course of radiotherapy.

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Study Officials

• Michael Reilly

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 31, 2018
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 1, 2023

Record last verified: 2022-08

Locations

US (1)