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

The Washington University

Status: Completed

Conditions: Cancer of Pancreas; Cancer of Abdomen; Cancer of Thorax; Cancer of Pelvis

Treatments: Device: Ring gantry kV-CBCT combined with linear accelerator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04008537

201908024

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

37 participants in 1 patient group

Halcyon kV CBCT imaging

Experimental group

Description:

-Each patient will undergo five Halcyon kV CBCT imaging sessions that will then be utilized to simulate the CBCT-guided online ART workflow. Halcyon imaging will be scheduled as per the patient's schedule and availability, with intent but not mandate for imaging on the same days as clinical treatments, preceding clinical treatment. Multiple images may be acquired in one session but no more than 6 Halcyon kV CBCT images will be acquired per day. No more than 6 additional Halcyon kV CBCT images will be acquired in one imaging session and no more than 10 total additional Halcyon kV CBCT images for the duration of the study

Treatment:

Device: Ring gantry kV-CBCT combined with linear accelerator