Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

NCT ID: NCT05427214

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-19

Study Completion Date

2024-10-17

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Halcyon 4.0 imaging

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.

Group Type EXPERIMENTAL

Halcyon 4.0 system

Intervention Type DEVICE

During each of the 1 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.

Interventions

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Halcyon 4.0 system

During each of the 1 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varian Medical Systems

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Samson, M.D., MPHS

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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202205118

Identifier Type: -

Identifier Source: org_study_id

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