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

Lawson Health Research Institute

Status: Enrolling

Conditions: Advanced Cancer Requiring Palliative Radiation

Treatments: Diagnostic Test: Standard of Care; Diagnostic Test: Diagnostic-CT-enabled Planning

Study type: Interventional

Funder types: Other

Identifiers

NCT05233904

DART

Details and patient eligibility

About

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

Enrollment: 33 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Patients will be booked for CT simulation and treatment as per the local institution's standard practice.

Treatment:

Diagnostic Test: Standard of Care

Experimental Treatment Workflow

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Diagnostic-CT-enabled Planning