Hypersight and Ethos In Pediatric Radiotherapy (Peds Ethos)

April 14, 2026 updated by: University Health Network, Toronto

Hypersight and Ethos In Pediatric Radiotherapy (Peds Ethos)

This is a single-center, prospective pilot study evaluating the utility of HyperSight CBCT imaging and Ethos adaptive radiation planning in pediatric patients receiving radiation therapy for non-cranial tumors.

Twenty patients aged 18 or under will be enrolled. Participants will receive standard-of-care radiation therapy, with the addition of twice-weekly HyperSight CBCT scans. These scans will be used to assess anatomical changes and generate adapted radiation plans using the Ethos platform. Radiation oncologists and radiation therapists will independently evaluate the need for adaptation, and adapted vs. scheduled plans will be compared using dosimetric and anatomical similarity metrics.

An optional sub-study will allow anonymized imaging and planning data to be shared with Varian Medical Systems. The study duration will match the patient's treatment course, typically 1-6 weeks, with no additional follow-up beyond standard care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient (paediatric or adolescent) age 18 or under receiving at least 5 days of radiation therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3

Exclusion Criteria:

- Patients with primary cranial tumours will be excluded due to the low expected utility of non-contrast CT scans in the delineation of brain edema and brain substructures.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Imaging
Participants will receive standard-of-care radiation therapy, with the addition of twice-weekly HyperSight CBCT scans.
Device: HyperSight CBCT scans
During the standard of care pediatric radiation treatment, a Cone Beam Computed Tomography (CBCT) image is taken after the patient is positioned on the radiation treatment table. This image, captured using equipment built into the treatment machine, helps ensure accurate alignment and allows assessment of tumor or tissue changes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dice Similarity Coefficient
Time Frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Change in Tumor and OAR Anatomy During Pediatric Radiation Therapy Using HyperSight CBCT and Ethos Adaptive Replanning. This outcome measures how tumor and organ-at-risk (OAR) anatomy changes during pediatric radiation therapy using HyperSight CBCT.
From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Hausdorff distance
Time Frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Change in Tumor and OAR Anatomy During Pediatric Radiation Therapy Using HyperSight CBCT and Ethos Adaptive Replanning. This outcome measures how tumor and organ-at-risk (OAR) anatomy changes during pediatric radiation therapy using HyperSight CBCT. This will be measured in mm.
From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Volume differences
Time Frame: Time Frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Change in Tumor and OAR Anatomy During Pediatric Radiation Therapy Using HyperSight CBCT and Ethos Adaptive Replanning. This outcome measures how tumor and organ-at-risk (OAR) anatomy changes during pediatric radiation therapy using HyperSight CBCT. This will be measured in cm^3.
Time Frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of cone beam CT
Time Frame: From baseline to end of treatment (approximately 6 to 8 weeks)
Using the 5 liker scale
From baseline to end of treatment (approximately 6 to 8 weeks)
Organ motion
Time Frame: From baseline to end of treatment (approximately 6 to 8 weeks)
Does the dose to the organ that day violate the prespecified constraints
From baseline to end of treatment (approximately 6 to 8 weeks)
Feasibility of Conformal Planning in Traditionally Field-Based Diseases
Time Frame: From baseline to end of treatment (approximately 6 to 8 weeks)
All target coverage goals achieved with conformal planning measured in percentage (%).
From baseline to end of treatment (approximately 6 to 8 weeks)
Feasibility of Conformal Planning in Traditionally Field-Based Diseases
Time Frame: From baseline to end of treatment (approximately 6 to 8 weeks)
All target coverage goals achieved with conformal planning measured in volume (mm^3)
From baseline to end of treatment (approximately 6 to 8 weeks)
Feasibility of Conformal Planning in Traditionally Field-Based Diseases
Time Frame: From baseline to end of treatment (approximately 6 to 8 weeks)
All target coverage goals achieved with conformal planning measured in dose (gy)
From baseline to end of treatment (approximately 6 to 8 weeks)
Dosimetric Impact of Adaptive Radiation Therapy
Time Frame: From baseline to end of treatment (approximately 6 to 8 weeks)
Measures the differences in accumulated radiation dose to the tumor and organs at risk (OARs) between adapted and non-adapted treatment plans using dose-volume metrics.
From baseline to end of treatment (approximately 6 to 8 weeks)
Safety of Minimized Target Expansion Volumes
Time Frame: From baseline to end of treatment (approximately 6 to 8 weeks)
Evaluates whether reducing target margins in adaptive planning maintains safe dose coverage while avoiding increased exposure to surrounding healthy tissue. All target coverage goals achieved with smaller PTV sizes. It's a pre-defined metric that is specific to the tumour type. A common example is the dose to 95% of the PTV should be >95% of the prescription dose.
From baseline to end of treatment (approximately 6 to 8 weeks)
Integration of Radiation Therapy Proficiencies in Adaptive Planning
Time Frame: From baseline to end of treatment (approximately 6 to 8 weeks)
Image review, contour adjustments, and plan selection during daily treatment sessions. Measured >=0.70 Dice Similarity Coefficient between radiation oncology and radiation therapy delineations.
From baseline to end of treatment (approximately 6 to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-5372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

To be discussed with PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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