Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

NCT05427214 | Completed DMC FDA Device

• 1 other identifier: 202205118
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  If the treatment target and surrounding organs at risk can be visualized and contoured for treatment planning purposes and a treatment plan created that meets the stated objectives ( or better than the stated objectives), then the kV CBCT images will be deemed feasible.

  At 9 weeks

Study Arms (1)

Halcyon 4.0 imaging

EXPERIMENTAL

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.

Device: Halcyon 4.0 system

Interventions

Halcyon 4.0 system 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.

Halcyon 4.0 imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Brain Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Stomach Neoplasms; Ovarian Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases

Study Officials

• Pamela Samson, M.D., MPHS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: August 19, 2022
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)