Unspecified Adult Solid TumorNCT03789773
Holographic Mm-Wave Imaging in Patients Undergoing Radiation Therapy
A study testing Millimeter-Wave Holographic Imaging in people with Unspecified Adult Solid Tumor, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor
- What is being tested?
- Millimeter-Wave Holographic Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients that are not scheduled for fluoroscopic or optical imaging as part of the normal course of radiotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To obtain patient images in a clinical setting and assess their quality.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Unspecified Adult Solid Tumor
- Being tested
- Millimeter-Wave Holographic Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Millimeter-Wave Holographic ImagingDevice
Also called Holographic Millimeter-wave Imaging; Holographic mm-Wave Imaging; MMW Holographic Imaging; Millimeter-wave Imaging; MMW Imaging; MMW
Undergo mm-wave holographic imaging
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (holographic mm-wave imaging) | Experimental | Patients undergo holographic mm-wave imaging in radiotherapy treatment position after initial CT simulation. Receives: Device: Millimeter-Wave Holographic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The distribution of the percent of points in voxel-voxel analysis to agree to better than 2 mm will be tabulated
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: Grant ended, no accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid TumorStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Reilly, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789773
- Sponsor's protocol ID
- 0S-18-6
- Other IDs
- NCI-2018-02994, 0S-18-6, P30CA014089
- Status last verified
- Aug 2022
- First submitted
- 27 Dec 2018
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holographic Mm-wave Imaging in Radiation Oncology
- ClinicalTrials.gov ID
- NCT03789773
- Acronym / sponsor ID
- 0S-18-6
- Conditions
- Unspecified Adult Solid Tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant ended, no accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To obtain patient images in a clinical setting and assess their quality.
SECONDARY OBJECTIVES:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (holographic mm-wave imaging) | Experimental | Device: Millimeter-Wave Holographic ImagingPatients undergo holographic mm-wave imaging in radiotherapy treatment position after initial CT simulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients that are not scheduled for fluoroscopic or optical imaging as part of the normal course of radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Millimeter-Wave Holographic ImagingAlso: Holographic Millimeter-wave Imaging; Holographic mm-Wave Imaging; MMW Holographic Imaging; Millimeter-wave Imaging; MMW Imaging; MMWUndergo mm-wave holographic imaging | Device | Diagnostic (holographic mm-wave imaging) |
Primary outcome
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.
1 secondary outcome
Image registration agreement between mm-wave holographic images and a cone-beam computed tomography (CBCT)/optical surface image
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Reilly principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Millimeter-Wave Holographic Imaging in people with Unspecified Adult Solid Tumor, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of holographic image quality (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.