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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05233904
Collaborator
(none)
33
Enrollment
1
Location
2
Arms
13.8
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnostic-CT-enabled Planning
  • Diagnostic Test: Standard of Care
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy
Actual Study Start Date :
Jun 8, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 London Health Sciences Centre London Ontario Canada N6A 5W9

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Palma, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT05233904
Other Study ID Numbers:
  • DART
First Posted:
Feb 10, 2022
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 13, 2022