Project Looking-Glass Evaluation

NCT06056063 | Active Not Recruiting FDA Device

• 2 other identifiers: UPCC 02923852966
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cone-Beam Computed Tomography

Outcome Measures

Primary Outcomes (4)

• 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

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

  1 year

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

  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)

  1 year

• 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

  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

  1 year

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

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

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (1)

Evaluate the Halcyon 4.0 obtained CBCT in comparison to a CT SIM for radiotherapy dose planning

EXPERIMENTAL

To evaluate the Halcyon 4.0 as a machine that will obtain CBCT that will be comparable to a CT simulator for radiotherapy treatment planning dose calculation. The novel CBCT images of subjects with malignancies from six disease sites obtained during the course of treatment for evaluation in place of the standard evaluation CBCT will be compared to their initial standard conventional CT simulation images used for treatment planning.

Device: Halcyon 4.0

Interventions

Halcyon 4.0 DEVICE

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

Evaluate the Halcyon 4.0 obtained CBCT in comparison to a CT SIM for radiotherapy dose planning

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Michelle Alonso-Basanta, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 28, 2023
• Study Start: November 19, 2023
• Primary Completion: October 11, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)