Hypersight and Ethos In Pediatric Radiotherapy

NCT07528547 | Recruiting

• 1 other identifier: 25-5372
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

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

• Organ motion

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

• Feasibility of Conformal Planning in Traditionally Field-Based Diseases

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

• Feasibility of Conformal Planning in Traditionally Field-Based Diseases

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

• Feasibility of Conformal Planning in Traditionally Field-Based Diseases

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

Study Arms (1)

Imaging

OTHER

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

Device: HyperSight CBCT scans

Interventions

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.

Imaging

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Dana Keilty, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: April 14, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CA (1)