NCT05233904

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

January 31, 2022

Last Update Submit

June 9, 2022

Conditions

Advanced Cancer Requiring Palliative Radiation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Diagnostic Test: Standard of Care

Experimental Treatment Workflow

EXPERIMENTAL

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

Interventions

Diagnostic-CT-enabled PlanningDIAGNOSTIC_TEST

Diagnostic-CT-enabled planning for patient receiving palliative radiation treatment to bone, soft tissue and lung disease

Experimental Treatment Workflow
Standard of CareDIAGNOSTIC_TEST

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

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (1)

  • O'Neil M, Nguyen TK, Laba J, Dinniwell R, Warner A, Palma DA. DART: diagnostic-CT-enabled planning: a randomized trial in palliative radiation therapy (study protocol). BMC Palliat Care. 2022 Dec 9;21(1):220. doi: 10.1186/s12904-022-01115-y.

    PMID: 36482335DERIVED

Study Officials

  • David Palma, MD

    London Health Sciences Centre, Lawson Health Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Palma, MD

CONTACT

519-685-8500David.Palma@lhsc.on.ca

Melissa O'Neil

CONTACT

Melissa.ONeil@lhsc.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 10, 2022

Study Start

June 8, 2022

Primary Completion

June 1, 2023

Study Completion

August 1, 2023

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)