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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06056063
Other study ID # UPCC 02923
Secondary ID 852966
Status Recruiting
Phase N/A
First received
Last updated
Start date November 19, 2023
Est. completion date September 2024

Study information

Verified date January 2024
Source Abramson Cancer Center at Penn Medicine
Contact Wei Xu
Phone 215-662-6083
Email weixu@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Truebeamâ„¢ or Halcyonâ„¢) unit either due to subject anatomy or treatment plan. - Those undergoing proton therapy.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Perelman Center for Advanced Medicine Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Evaluation of the suitability and workflow of the novel CBCT images for radiation treatment planning and dose calculation. The secondary endpoint is to compare the accuracies of dose and volume calculations to the standard arm using the conventional CT simulation. 1 year
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