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Recruiting NCT07528547

Hypersight and Ethos In Pediatric Radiotherapy

No phase Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HyperSight CBCT scans.
Who it may be relevant to
Registry conditions: Cancer. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Hypersight and Ethos In Pediatric Radiotherapy (Peds Ethos)

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (8)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Princess Margaret Cancer Centre — Toronto

Identifiers

NCT: NCT07528547 · 25-5372

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗