Hypersight and Ethos In Pediatric Radiotherapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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