Recruiting

HyperSight & Ethos

Sponsor:

University Health Network, Toronto

Code:

NCT07528547

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

HyperSight CBCT scans

Study Details

Brief 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. 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

Study ID

NCT07528547

Start date

Apr 14, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Imaging

Participants will receive standard-of-care radiation therapy, with the addition of twice-weekly HyperSight CBCT scans.

Interventions

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.

Primary outcome measure

  • Dice Similarity Coefficient [ Time Frame: 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. ]
  • Volume differences [ Time Frame: Time Frame: From baseline (start of radiation treatment) to end of treatment, approximately 6 to 8 weeks. ]

Central Contacts and Locations

Central contacts

Dana Keilty, MD

416-946-4501dana.keilty@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Dana Keilty, MD

416-946-4501dana.keilty@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-04-15.