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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer Requiring Palliative Radiation
• Intervention / Treatment: Diagnostic test: Standard of Care; Diagnostic test: Diagnostic-CT-enabled Planning

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Palma, MD; Phone Number: 519-685-8500; Email: David.Palma@lhsc.on.ca
• Study Contact Backup: Name: Melissa O'Neil; Email: Melissa.ONeil@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre
      • Contact: David Palma, MD; Phone Number: 519-685-8500; Email: David.Palma@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Patients will be booked for CT simulation and treatment as per the local institution's standard practice.	Diagnostic test: Standard of Care; Patients will be booked for CT simulation and treatment as per the local institution's standard practice
Experimental: Experimental Treatment Workflow; 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.	Diagnostic test: Diagnostic-CT-enabled Planning; Diagnostic-CT-enabled planning for patient receiving palliative radiation treatment to bone, soft tissue and lung disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Centre (TIC) on 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.	1 Treatment Day

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: David Palma, MD, London Health Sciences Centre, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No