Cancer
Conditions
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.
Interventions
DEVICEHyperSight 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dice Similarity Coefficient | 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 | 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: 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of cone beam CT | From baseline to end of treatment (approximately 6 to 8 weeks) | Using the 5 liker scale |
| Organ motion | From baseline to end of treatment (approximately 6 to 8 weeks) | Does the dose to the organ that day violate the prespecified constraints |
| Feasibility of Conformal Planning in Traditionally Field-Based Diseases | From baseline to end of treatment (approximately 6 to 8 weeks) | All target coverage goals achieved with conformal planning measured in percentage (%). |
| Dosimetric Impact of Adaptive Radiation Therapy | 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. |
| Safety of Minimized Target Expansion Volumes | 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. |
| Integration of Radiation Therapy Proficiencies in Adaptive Planning | 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. |
Countries
Canada
Contacts
CONTACTDana Keilty, MD
Outcome results
None listed