CancerPeds EthosNCT07528547
Hypersight and Ethos In Pediatric Radiotherapy
A study testing HyperSight CBCT scans in people with Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- HyperSight CBCT scans
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Dana Keilty, MD, 416-946-4501 ext. 6513, dana.keilty@uhn.ca
About this study
Official title: 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.
- Conditions
- Cancer
- Being tested
- HyperSight CBCT scans
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperSight CBCT scansDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Other | Participants will receive standard-of-care radiation therapy, with the addition of twice-weekly HyperSight CBCT scans. Receives: Device: HyperSight CBCT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dice Similarity Coefficient
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.
Measured: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Hausdorff distance
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.
Measured: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Volume differences
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.
Measured: Time Frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.
Secondary outcomes (8)
Quality of cone beam CT
Using the 5 liker scale
Measured: From baseline to end of treatment (approximately 6 to 8 weeks)
Organ motion
Does the dose to the organ that day violate the prespecified constraints
Measured: From baseline to end of treatment (approximately 6 to 8 weeks)
Feasibility of Conformal Planning in Traditionally Field-Based Diseases
All target coverage goals achieved with conformal planning measured in percentage (%).
Measured: From baseline to end of treatment (approximately 6 to 8 weeks)
Feasibility of Conformal Planning in Traditionally Field-Based Diseases
All target coverage goals achieved with conformal planning measured in volume (mm^3)
Measured: From baseline to end of treatment (approximately 6 to 8 weeks)
Feasibility of Conformal Planning in Traditionally Field-Based Diseases
All target coverage goals achieved with conformal planning measured in dose (gy)
Measured: From baseline to end of treatment (approximately 6 to 8 weeks)
Dosimetric Impact of Adaptive Radiation Therapy
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.
Measured: From baseline to end of treatment (approximately 6 to 8 weeks)
Safety of Minimized Target Expansion Volumes
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.
Measured: From baseline to end of treatment (approximately 6 to 8 weeks)
Integration of Radiation Therapy Proficiencies in Adaptive Planning
Image review, contour adjustments, and plan selection during daily treatment sessions. Measured >=0.70 Dice Similarity Coefficient between radiation oncology and radiation therapy delineations.
Measured: From baseline to end of treatment (approximately 6 to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start14 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528547
- Sponsor's protocol ID
- 25-5372
- Acronym
- Peds Ethos
- Status last verified
- Apr 2026
- First submitted
- 26 May 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be discussed with PI
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypersight and Ethos In Pediatric Radiotherapy (Peds Ethos)
- ClinicalTrials.gov ID
- NCT07528547
- Acronym / sponsor ID
- Peds Ethos / 25-5372
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Apr 2026 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging | Other | Device: HyperSight CBCT scansParticipants will receive standard-of-care radiation therapy, with the addition of twice-weekly HyperSight CBCT scans. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| HyperSight CBCT scansDuring 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. | Device | Imaging |
Primary outcome
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.
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.
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.
8 secondary outcomes
Quality of cone beam CT
Time frame: 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)
Feasibility of Conformal Planning in Traditionally Field-Based Diseases
Time frame: 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)
Feasibility of Conformal Planning in Traditionally Field-Based Diseases
Time frame: 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)
Safety of Minimized Target Expansion Volumes
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided. To be discussed with PI
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HyperSight CBCT scans in people with Cancer, run by University Health Network, Toronto at 1 site in Canada.
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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Keilty, MD (416-946-4501 ext. 6513, dana.keilty@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dice Similarity Coefficient (time frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks.). The study lists 3 primary outcomes in all. 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 15 Apr 2026.