Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device

Cancer of Pancreas Clinical Trial

Official title:

A Pilot Study of Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008537
• Other study ID #: 201908024
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: March 8, 2022

Study information

• Verified date: April 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose here to evaluate the feasibility of a novel cone-beam CT (CBCT)-guided online adaptive radiotherapy (ART) workflow on the Halcyon device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least one disease site deemed to be suitable for simulated treatment with online adaptive radiotherapy per radiation oncology evaluation.

• Scheduled to receive radiation therapy to the thorax (n = 8), pancreas (n = 8), non-pancreas abdomen (n = 8), or pelvis (n = 8).

• At least 18 years of age

• Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of a pregnancy test.

Related Conditions & MeSH terms

• Cancer of Abdomen
• Cancer of Pancreas
• Cancer of Pelvis
• Cancer of Thorax
• Pancreatic Neoplasms
• Pelvic Neoplasms

Intervention

Device:
• Ring gantry kV-CBCT combined with linear accelerator
Each imaging session will be less than one hour, and is expected to take no more than 15 minutes.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the device as measured by successful completion of the full CBCT-guided online ART workflow, from volumetric imaging through phantom delivery in at least 90% of attempted fractions		Completion of ART workflow in all enrolled participants (estimated to be 30 months)

External Links

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