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Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy (Dragon)

Primary Purpose

Brain Cancer, Head and Neck Cancer, Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Halcyon 4.0 system

About this trial

This is an interventional device feasibility trial for Brain Cancer focused on measuring radiation therapy, halcyon, brain radiation, thoracic radiation, abdominal radiation, pelvic radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria:

Scheduled to receive radiation therapy to one of the following sites:
- Head and neck/brain (n=10)
- Thorax (n=10)
- Abdomen (n=10)
- Pelvis (n=10)
At least 18 years of age
If the patient will be receiving IV contrast on study: Adequate renal function as defined by a serum creatinine < 1.4, or, for patients with chronic kidney disease, a stable serum creatinine < 2.0. Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented.
If the patient is a woman of childbearing potential, a negative pregnancy test must be obtained. Contraceptive use is not an adequate documentation of no chance of pregnancy.
Able to understand and willing to sign an IRB approved written informed consent document.

Sites / Locations

Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Halcyon 4.0 imaging

Arm Description

Patients planning to receive radiation therapy to the head and neck/brain, thorax, abdomen, or pelvis will undergo imaging on the Halcyon 4.0 system. Patients will return for a minimum of 2 sessions over 9 weeks, with a cumulative total of 10 images being collected.

Outcomes

Primary Outcome Measures

Percentage of images that are of sufficient quality for patient primary treatment plan construction

Images evaluated by radiation oncologist for radiation therapy adequacy. Feasibility will be defined as a success rate of >80%.

Secondary Outcome Measures

Full Information

NCT ID

NCT05427214

First Posted

June 16, 2022

Last Updated

May 24, 2023

Sponsor

Washington University School of Medicine

Collaborators

Varian Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT05427214

Brief Title

Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

Acronym

Dragon

Official Title

A Prospective Imaging Study of Target Definition and Simulation-free Planning Workflows on the Halcyon 4.0 System for Patients Receiving Radiation Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 19, 2022 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

May 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

Varian Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This prospective imaging study is evaluating the feasibility of using the Halcyon 4.0 radiotherapy system for radiation therapy planning in patients with cancer. The Halcyon 4.0 system has been engineered to decrease the image acquisition time and the radiation exposure, but the system has not yet been clinically validated for use in radiation planning. This pilot study will evaluate images obtained on the Halcyon 4.0 system to assess if the quality is sufficient for radiation treatment plan construction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Cancer, Head and Neck Cancer, Lung Cancer, Gastric Cancer, Ovarian Cancer, Colon Cancer

Keywords

radiation therapy, halcyon, brain radiation, thoracic radiation, abdominal radiation, pelvic radiation

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Halcyon 4.0 imaging

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Halcyon 4.0 system

Intervention Description

During each of the 2 or more imaging sessions, no more than 6 images total will be acquired. Only 5 images total across all of the imaging sessions will be used toward the study endpoint.

Primary Outcome Measure Information:

Title

Percentage of images that are of sufficient quality for patient primary treatment plan construction

Description

Images evaluated by radiation oncologist for radiation therapy adequacy. Feasibility will be defined as a success rate of >80%.

Time Frame

At 9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria: Planning to receive radiation therapy to one of the following sites: Head and neck/brain (n=10) Thorax (n=10) Abdomen (n=10) Pelvis (n=10) At least 18 years of age If the patient will be receiving IV contrast on study: Adequate renal function as defined by a serum creatinine < 1.4, or, for patients with chronic kidney disease, a stable serum creatinine < 2.0. Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented. If the patient is a woman of childbearing potential, a negative pregnancy test must be obtained. Contraceptive use is not an adequate documentation of no chance of pregnancy. Able to understand and willing to sign an IRB approved written informed consent document.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pamela Samson, M.D., MPHS

Phone

314-801-3806

psamson@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela Samson, M.D., MPHS

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pamela Samson, M.D., MPHS

Phone

314-801-3806

psamson@wustl.edu

First Name & Middle Initial & Last Name & Degree

Pamela Samson, M.D., MPHS

First Name & Middle Initial & Last Name & Degree

James Cordova, M.D.

First Name & Middle Initial & Last Name & Degree

Tianyu Zhao, Ph.D.

First Name & Middle Initial & Last Name & Degree

Lauren Henke, M.D., MSCI

First Name & Middle Initial & Last Name & Degree

Alex Price, M.S.

First Name & Middle Initial & Last Name & Degree

Hyun Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Hua Li, Ph.D.

First Name & Middle Initial & Last Name & Degree

Eric Laugeman, M.S.

First Name & Middle Initial & Last Name & Degree

Taeho Kim, Ph.D.

First Name & Middle Initial & Last Name & Degree

Nels Knutson, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

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