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

The Washington University

Status: Active, not recruiting

Conditions: Gastric Cancer; Colon Cancer; Lung Cancer; Ovarian Cancer; Head and Neck Cancer; Brain Cancer

Treatments: Device: Halcyon 4.0 system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05427214

202205118

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Halcyon 4.0 imaging

Experimental group

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.

Treatment:

Device: Halcyon 4.0 system