On-treatment Adaptation of Head and Neck Cancer Dosimetry Plans Using Novel Cone-beam CT and AI-driven Software

NCT05666193 | Completed FDA Device

• 1 other identifier: VAR-2022-06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility study investigating the use of a high-performance HyperSight cone beam CT (CBCT) and adaptive planning software for both online and offline radiotherapy treatment planning for head and neck cancer.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (4)

• Evaluation of CBCT-based dosimetry calculations

  The treatment plan calculated on a subject's fan beam simulation CT will be re-calculated on both the HyperSight CBCT acquired on the day of the subject's simulation CT and on the TrueBeam CBCT used for subject positioning during fraction 1 of treatment delivery. Dose-volume histograms for targets and key organs at risk will be compared between the three dose calculations from each subject.

  1 day

• Evaluate potential reduction in time and resources required for offline plan adaptation

  The workflow and opportunity for improved efficiency when using HyperSight CBCT images for offline treatment adaptation, will be compared to the standard process of obtaining a separate FBCT for re-planning. The average time required to generate a revised treatment plan will be measured and compared to institutional norms.

  4 weeks

• Improvements in radiation dosimetry from using online adaptation

  The HyperSight CBCT acquired on the same day as the subject's 21st treatment fraction delivery will be used to simulate an online adaptive radiotherapy session, which will produce a treatment plan that is adapted to the anatomy as it appears on that day. The target dose coverage and doses delivered to key organs at risk in the adaptive plan will be compared to the doses that are delivered to those structures by the subject's initial treatment plan.

  4 weeks

• Qualitative assessment of CBCT imaging

  Paired HyperSight CBCT and Truebeam CBCT images will be presented to radiation oncologists and radiation therapists, who will rank the images using a Likert scale for the ability to identify significant anatomical structure volume changes that prompt the need for on-treatment replanning.

  4 weeks

Secondary Outcomes (2)

• CBCT image quality

  4 weeks

• Patient experience questionnaire

  1 day

Study Arms (1)

HyperSight Imaging Arm

EXPERIMENTAL

Subjects imaged with the new HyperSight CBCT imaging system.

Device: CBCT Imaging

Interventions

CBCT Imaging DEVICE

Subjects are scheduled for two imaging sessions on the Ethos system with the HyperSight CBCT. One session is on the same day as the CT simulation scan for treatment planning. The second session is on the same day as the delivery of ther 21st treatment fraction. If the subject is sent for a mid-treatment FBCT for re-planning, a third HyperSight CBCT imaging session will be scheduled on the same day as the mid-treatment FBCT.

HyperSight Imaging Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age ≥ 19
• Patient is scheduled for treatment on one of the five TrueBeam platforms at the NS Health QE2 site.
• Patient is receiving radiation therapy for cancer of the head and neck involving a target in either the ipsilateral or bilateral neck, with a minimum of 21 fractions.

You may not qualify if:

• Patient is pregnant or has plans for pregnancy during the period of treatment.
• Patient is unwilling to consent to participating to the study, or for whom informed consent is not possible.
• Patient has previously undergone radiation therapy to the oral cavity or sinuses.
• Patient has had either a bilateral neck dissection and/or laryngectomy.

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (1)

Nova Scotia Health (QEII)

Halifax, Nova Scotia, B3H 2E2, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

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

Model Details: This is a prospective, single-arm, single-site feasibility study designed to generate data describing the quality and applicability of on-couch high-performance CBCT imaging technology during external beam radiation therapy for head and neck cancer patients.

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 27, 2022
• Study Start: July 10, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)