DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy

Not Applicable

• Conditions: Advanced Cancer Requiring Palliative Radiation
• Interventions: Diagnostic Test: Standard of Care; Diagnostic Test: Diagnostic-CT-enabled Planning

• Registration Number: NCT05233904
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

The objective of this trial is to assess the efficacy, acceptability, and scalability of diagnostic-CT-enabled planning, compared to conventional CT simulation planning.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Status Verified: 2022-06
• Study Start: 2022-06-08
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-13
• Primary Completion: 2023-06-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Age 18 years or older
• Able to provide informed consent
• Patient has consented to PRT to bone/soft tissue metastases or primary targets in the thorax, abdomen, or pelvis and RO will use simple planning techniques (i.e. parallel-opposed pair or direct field beam arrangement)
• Patient will be scheduled for same-day simulation and treatment (if randomized to Arm 1)
• Patient has a pre-existing and recent (i.e. within 4 weeks of time of enrollment) diagnostic CT or CT-fused scan with full visualization of the region-of-interest which has been acquired from an approved diagnostic scanner
• Patient positioning scan is deemed acceptable and reproducible (e.g., patient is lying supine and relatively flat, there is no/minimal motion blur, ect.)
• Intravenous (IV)/oral contrast in the region-of-interest is permitted as long as it does not create artifact which obscured the target volume (density override calculations may be required)

Exclusion Criteria

• Any contraindication to receiving radiation
• Oncologic emergencies and/or on-call cases
• Pregnant or lactating women
• Cases requiring composite dosimetric planning to account for previous radiotherapy or extended distance set-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Patients will be booked for CT simulation and treatment as per the local institution's standard practice.
Experimental Treatment Workflow	Diagnostic-CT-enabled Planning	Patients do not require a CT simulation appointment. A radiation treatment appointment will be scheduled on an optical surface guidance-equipped treatment unit as soon as available, but a minimum of 24 hours is required between EBAF processing and fraction 1.

Primary Outcome Measures

Name	Time	Method
Time in Centre (TIC) on Treatment Day	1 Treatment Day	This is defined as the total time in hours spent at the cancer centre from the scheduled CT simulation (Arrm 1) or treatment delivery (Arm 2) appointment until beam delivery completion.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada