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NCT Number: NCT07528547

Hypersight and Ethos In Pediatric Radiotherapy

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.

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Key information

Conditions

Cancer Neoplasms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Dana Keilty, MD

CONTACT

[email protected]

416-946-4501 ext. 6513

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HyperSight CBCT scans

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Quality of cone beam CT

    Time frame: From baseline to end of treatment (approximately 6 to 8 weeks)

    Using the 5 liker scale

  2. 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

  3. 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 (%).

  4. 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)

  5. 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)

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dana Keilty, MD

CONTACT

[email protected]

416-946-4501 ext. 6513

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Hypersight and Ethos In Pediatric Radiotherapy (Peds Ethos)

Acronym: Peds Ethos

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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