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Procedure

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

N/A

Recruiting

Led By Michelle Alonso-Basanta, MD, PhD

Research Sponsored by Abramson Cancer Center at Penn Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new way of using CT scans for radiation therapy treatment planning.

Who is the study for?

This trial is for adults over 18 who are set to receive external beam radiotherapy at the Perelman Center for cancers like head-and-neck, thoracic, breast, gastrointestinal, gynecologic or genitourinary. They must understand the study and consent to it. A full treatment plan with CT images and radiation prescriptions is required.Check my eligibility

What is being tested?

The pilot study is testing Halcyon 4.0's new design in Cone-Beam CT imaging technology used during radiation therapy treatment simulation to see how well it works and fits into clinical workflows.See study design

What are the potential side effects?

Since this trial focuses on validating imaging technology rather than a drug or medical procedure, direct side effects from the intervention itself are not anticipated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will receive radiotherapy at the Perelman Center for cancers like head, neck, lung, breast, stomach, reproductive organs.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+1 more

Secondary outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Evaluate the Halcyon 4.0 obtained CBCT in comparison to a CT SIM for radiotherapy dose planningExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,608 Total Patients Enrolled

Varian Medical SystemsIndustry Sponsor

59 Previous Clinical Trials

3,743 Total Patients Enrolled

Michelle Alonso-Basanta, MD, PhDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are they currently accepting participants for this research study?

"Indeed, as per clinicaltrials.gov, this research study is actively seeking eligible participants. The trial was initially posted on November 19th, 2023 and underwent its most recent update on January 12th, 2024."

Answered by AI

How many participants are currently undergoing treatment in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible candidates. The initial posting of this study was made on November 19th, 2023 and it underwent its last update on January 12th, 2024. This research aims to include a total of 36 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Project Looking-Glass Evaluation

2023. "Project Looking-Glass Evaluation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06056063.