Clinical trial NCT06056063: Project Looking-Glass Evaluation
Official title: Evaluation of Novel CT Imaging for Simulation on a Linear Accelerator
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cone-Beam Computed Tomography
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Varian Medical Systems
First posted: 2023-09-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 year
measure: Ease of use of the novel cone-beam CT imaging system compared to standard practice
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Statistical significance of quantitative comparison of the image quality of the novel cone-beam CT imaging system and standard practice
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of the suitability and workflow of the novel CBCT images for radiation treatment planning and dose calculation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michelle Alonso-Basanta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: