Advanced Cancer Requiring Palliative RadiationDARTNCT05233904
DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy
A study testing Diagnostic-CT-enabled Planning in people with Advanced Cancer Requiring Palliative Radiation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer Requiring Palliative Radiation
- What is being tested?
- Diagnostic-CT-enabled Planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2022to 5 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
The objective of this trial is to assess the efficacy, acceptability, and scalability of diagnostic-CT-enabled planning, compared to conventional CT simulation planning.
- Being tested
- Diagnostic-CT-enabled Planning, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic-CT-enabled PlanningDiagnostic test
Diagnostic-CT-enabled planning for patient receiving palliative radiation treatment to bone, soft tissue and lung disease
Standard of CareDiagnostic test
Patients will be booked for CT simulation and treatment as per the local institution's standard practice
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Patients will be booked for CT simulation and treatment as per the local institution's standard practice. Receives: 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. Receives: Diagnostic Test: Diagnostic-CT-enabled Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Treatment Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start8 Jun 2022
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Cancer Requiring Palliative RadiationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Palma, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- David Palma, MD, Principal investigator, London Health Sciences Centre, Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233904
- Sponsor's protocol ID
- DART
- Acronym
- DART
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36482335
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy
- ClinicalTrials.gov ID
- NCT05233904
- Acronym / sponsor ID
- DART / DART
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Diagnostic Test: Standard of CarePatients will be booked for CT simulation and treatment as per the local institution's standard practice. |
| Experimental Treatment Workflow | Experimental | Diagnostic Test: Diagnostic-CT-enabled PlanningPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic-CT-enabled PlanningDiagnostic-CT-enabled planning for patient receiving palliative radiation treatment to bone, soft tissue and lung disease | Diagnostic test | Experimental Treatment Workflow |
| Standard of CarePatients will be booked for CT simulation and treatment as per the local institution's standard practice | Diagnostic test | Standard of Care |
Primary outcome
Time in Centre (TIC) on Treatment Day
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 36482335O'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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Palma, MD principal investigator
London Health Sciences Centre, Lawson Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic-CT-enabled Planning in people with Advanced Cancer Requiring Palliative Radiation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Centre (TIC) on Treatment Day (time frame: 1 Treatment Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.