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Active, Not Recruiting

NCT Number: NCT06056063

Project Looking-Glass Evaluation

Pilot study to validate the new design and workflow of Cone-Beam CT imaging for radiation therapy treatment simulation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

This study is a prospective, non-randomized imaging evaluation study. A cohort of subjects undergoing standard of care radiation therapy will be selected based on malignancies from six disease sites. The Halcyon 4.0 images acquired in place of standard evaluation CT scans during the course of treatment will be used for target volume delineation and normal structures segmentation. Treatment plans will be recalculated based on the Halcyon 4.0 images from this system and compared to the original treatment plan. Dose differences will be evaluated. Two-tailed t-test will be used to compare the statistical significance of the dosimetric results as well as the volumetric differences among target volume and the volumes of organs at risk.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects will be treated with external beam radiotherapy at the Perelman Center for Advanced Medicine for any of the following malignancies: head-and-neck, thoracic, breast, gastrointestinal, gynecologic, or genitourinary.
  • Age ≥ 18 years
  • Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
  • Availability of a complete set of treatment plans, including CT simulation images, target and normal structure contours, and radiation treatment prescriptions

Exclusion criteria

  • Subjects who are pregnant or have plans for pregnancy during the period of treatment.
  • Any malignancy not stated above.
  • Those unable to be treated on any linear accelerator (whether Truebeam™ or Halcyon™) unit either due to subject anatomy or treatment plan.
  • Those undergoing proton therapy.

Treatment and study plan

Halcyon 4.0

Device

This Halcyon 4.0 is a new imaging hardware recently developed by Varian and approved by the FDA.

Primary outcomes

  1. Acceptability of image quality of the novel cone-beam CT imaging system compared to that of standard cone-beam CT imaging and that of conventional fan beam CT imaging used for radiotherapy planning purposes

    Time frame: 1 year

    Qualitative results (Yes is acceptable/No is not acceptable) will be reported as tabulated data to demonstrate the differences from the standard practice

  2. Ease of use of the novel cone-beam CT imaging system compared to standard practice

    Time frame: 1 year

    Ease of use of the novel cone-beam CT imaging system on a scale of 1 (very easy to use, no difficulty) to 5 (unable to use due to difficulty)

  3. Quantitative comparison of the image quality of the novel cone-beam CT imaging system to that of standard cone-beam CT imaging and that of conventional fan beam CT imaging used for radiotherapy planning purposes

    Time frame: 1 year

    A scale of Better/Worse/Equal will be used for metrics such as CBCT image artifact, CBCT image quality for OAR contouring, CBCT image quality for GTV contouring, motion artifacts, auto-segmentation ability, electron density similarity

  4. Statistical significance of quantitative comparison of the image quality of the novel cone-beam CT imaging system and standard practice

    Time frame: 1 year

    For situations that the quantitative results will be measured, such as the structure volume or predicted electron densities etc., statistical significance will be calculated.

Secondary outcomes

  1. Evaluation of the suitability and workflow of the novel CBCT images for radiation treatment planning and dose calculation.

    Time frame: 1 year

    The secondary endpoint is to compare the accuracies of dose and volume calculations to the standard arm using the conventional CT simulation.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

Evaluation of Novel CT Imaging for Simulation on a Linear Accelerator

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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