Bone MetastasesdCT-PRTNCT06235034
Diagnostic CT Palliative Radiotherapy: Feasibility Study of Treating Bone Metastases Without a CT Simulation
A study testing Diagnostic CT in people with Bone Metastases, run by British Columbia Cancer Agency.
Trial summary
The purpose of this non-randomized, prospective study is to assess the feasibility of planning and delivering conventional palliative radiotherapy to bone metastases on previously available diagnostic CT scans (dCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Diagnostic CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2024to 30 Apr 2025
- 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
- Patients >18 years of age
- Able to provide informed consent
- Patient able to lie supine comfortably
- Patient is receiving conventional palliative radiotherapy (Parallel Opposed Pair or single field over 8/1 or 20/5) for the treatment of bone metastases in the following locations: T5-lumbosacral spine, Bony pelvis
- Patient has a diagnostic CT scan which includes the anatomic location to be treated that is within 28 days of enrollment
- Quality of dCT scan is deemed sufficient for RT planning as determined by medical physicist and RT
Who cannot join
- Patient unwilling, unable to consent to treatment/study
- Any contraindications to receiving radiotherapy including pregnancy
- Oncologic emergencies, on call treatments, or any indications for urgent radiotherapy
- Inability to comfortably maintain and immobilized position due to uncontrolled pain or co-morbidities
- Cases requiring VMAT planning or complex planning to account for prior courses of radiotherapy
- Cases using non-conventional palliative radiotherapy fractionations
- Anatomic sites outside of the pre-defined criteria above
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic CT Palliative Radiotherapy: Feasibility Study of Treating Bone Metastases
The purpose of this non-randomized, prospective study is to assess the feasibility of planning and delivering conventional palliative radiotherapy to bone metastases on previously available diagnostic CT scans (dCT).
Objectives:1) dosimetric accuracy of palliative radiotherapy designed on a dCT compared to a CT simulation 2) assess suitability of patient set up using surface landmarks and kilo voltage (kV) imaging 3) determine the proportion of patients who can receive radiotherapy designed on a dCT 4) confirm eligibility criteria for appropriate patients in clinical practice
All enrolled patients will undergo a CT simulation with tattoos as per current standard of care.The radiation oncologist will place fields on the dCT and CT simulation. Radiotherapy will be planned on both CT scans and reviewed for quality by both the radiation oncologist and medical physicist.
Read the detailed description
Purpose:
This prospective study aims to demonstrate the feasibility of delivering palliative radiotherapy designed on a diagnostic CT scan (dCT) for patients with bone metastases in the spine and bony pelvis.
Hypothesis:
At least eighty percent of patients will successfully receive radiotherapy as designed on the dCT.
Justification:
Currently, patients who require palliative radiotherapy for bone metastases undergo a CT simulation and tattoos to design their radiotherapy. However, many of these patients already have a diagnostic CT scan. Other cancer centres have developed protocols to design radiotherapy on diagnostic CT scans. This technique allows patients to avoid CT simulations which can delay access treatment and can be burdensome for frail patients. The successful implementation of a diagnostic CT palliative radiotherapy (dCT-RT) workflow could provide more timely access to radiotherapy for patients, decrease resource utilization (CT simulation time, radiation therapist and nursing time), and decrease the carbon footprint of this service by decreasing the number of trips required to the cancer centre.
Objectives:
Primary: 1) dosimetric accuracy of palliative radiotherapy designed on a dCT compared to a CT simulation 2) assess suitability of patient set up using surface landmarks and kilo voltage (kV) imaging 3) determine the proportion of patients who can receive radiotherapy designed on a dCT 4) confirm eligibility criteria for appropriate patients in clinical practice
Secondary: 1) patient satisfaction with treatment process 2) evaluate carbon footprint savings of dCT-RT workflow
Research Design and Statistical Analysis:
This non-randomized prospective feasibility study will enroll ten eligible patients. All study activities will take place at BC Cancer, Vancouver Centre. Eligible patients will have their dCT reviewed by a radiation oncologist and medical physicist to determine suitability for radiotherapy planning. All enrolled patients will undergo a CT simulation with tattoos as per current standard of care. Radiotherapy will be planned on both their dCT scan and CT simulation. Patient set up will be performed using surface landmarks and confirmed with KV imaging. Quality assurance (QA) per the centres standard of practice will occur for plan review, approval and treatment set up. If at any point during the QA process accepted standards are not met, radiotherapy with be delivered according to the standard practice CT simulation plan.
Patient, tumor and treatment factors will be collected from the electronic medical record (Cerner) and radiotherapy plan in Aria and evaluated using descriptive statistics. Dosimetric parameters between dCT and CT simulation plans will be compared. The suitability of the dCT-RT plan will be documented as yes/no. The time required to set up a patient up for the dCT-RT workflow on day one will be record. Suitability of patient set up and deliverability of dCT-RTplan will be documented as yes/no. Patient satisfaction will be assessed post treatment with a brief questionnaire and described using descriptive statistics. The carbon footprint saved by the dCT-RT method will be calculated by assessing the carbon footprint associated with travel from home (or hospital) to the cancer centre.
- Conditions
- Bone Metastases
- Being tested
- Diagnostic CT
- Keywords
- Palliative Radiation, CT Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic CTOther
radiotherapy will be designed on diagnostic CT. If plan is of sufficient quality, RT will be delivered to patient
| Study group | Role | What they receive |
|---|---|---|
| diagnostic CT | Experimental | patients will have their palliative radiotherapy designed on their diagnostic CT Receives: Other: Diagnostic CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosimetric accuracy of palliative radiotherapy designed on a dCT compared to a CT simulation
Measured: 1 Year
assess suitability of patient set up using surface landmarks and kilo voltage (kV) imaging
Measured: 1 Year
determine the proportion of patients who can receive radiotherapy designed on a dCT
Measured: 1 Year
confirm eligibility criteria for appropriate patients in clinical practice
Measured: 1 Year
Secondary outcomes (2)
patient satisfaction with treatment process
Measured: 1 Year
evaluate carbon footprint savings of dCT-RT workflow
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235034
- Sponsor's protocol ID
- dCT-PRT
- Acronym
- dCT-PRT
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic CT Palliative Radiotherapy: Feasibility Study of Treating Bone Metastases
- ClinicalTrials.gov ID
- NCT06235034
- Acronym / sponsor ID
- dCT-PRT / dCT-PRT
- Conditions
- Bone Metastases
- Keywords
- Palliative Radiation, CT Simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 31 Jan 2024 (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 purpose of this non-randomized, prospective study is to assess the feasibility of planning and delivering conventional palliative radiotherapy to bone metastases on previously available diagnostic CT scans (dCT).
Objectives:1) dosimetric accuracy of palliative radiotherapy designed on a dCT compared to a CT simulation 2) assess suitability of patient set up using surface landmarks and kilo voltage (kV) imaging 3) determine the proportion of patients who can receive radiotherapy designed on a dCT 4) confirm eligibility criteria for appropriate patients in clinical practice
All enrolled patients will undergo a CT simulation with tattoos as per current standard of care.The radiation oncologist will place fields on the dCT and CT simulation. Radiotherapy will be planned on both CT scans and reviewed for quality by both the radiation oncologist and medical physicist.
Detailed description
Purpose:
This prospective study aims to demonstrate the feasibility of delivering palliative radiotherapy designed on a diagnostic CT scan (dCT) for patients with bone metastases in the spine and bony pelvis.
Hypothesis:
At least eighty percent of patients will successfully receive radiotherapy as designed on the dCT.
Justification:
Currently, patients who require palliative radiotherapy for bone metastases undergo a CT simulation and tattoos to design their radiotherapy. However, many of these patients already have a diagnostic CT scan. Other cancer centres have developed protocols to design radiotherapy on diagnostic CT scans. This technique allows patients to avoid CT simulations which can delay access treatment and can be burdensome for frail patients. The successful implementation of a diagnostic CT palliative radiotherapy (dCT-RT) workflow could provide more timely access to radiotherapy for patients, decrease resource utilization (CT simulation time, radiation therapist and nursing time), and decrease the carbon footprint of this service by decreasing the number of trips required to the cancer centre.
Objectives:
Primary: 1) dosimetric accuracy of palliative radiotherapy designed on a dCT compared to a CT simulation 2) assess suitability of patient set up using surface landmarks and kilo voltage (kV) imaging 3) determine the proportion of patients who can receive radiotherapy designed on a dCT 4) confirm eligibility criteria for appropriate patients in clinical practice
Secondary: 1) patient satisfaction with treatment process 2) evaluate carbon footprint savings of dCT-RT workflow
Research Design and Statistical Analysis:
This non-randomized prospective feasibility study will enroll ten eligible patients. All study activities will take place at BC Cancer, Vancouver Centre. Eligible patients will have their dCT reviewed by a radiation oncologist and medical physicist to determine suitability for radiotherapy planning. All enrolled patients will undergo a CT simulation with tattoos as per current standard of care. Radiotherapy will be planned on both their dCT scan and CT simulation. Patient set up will be performed using surface landmarks and confirmed with KV imaging. Quality assurance (QA) per the centres standard of practice will occur for plan review, approval and treatment set up. If at any point during the QA process accepted standards are not met, radiotherapy with be delivered according to the standard practice CT simulation plan.
Patient, tumor and treatment factors will be collected from the electronic medical record (Cerner) and radiotherapy plan in Aria and evaluated using descriptive statistics. Dosimetric parameters between dCT and CT simulation plans will be compared. The suitability of the dCT-RT plan will be documented as yes/no. The time required to set up a patient up for the dCT-RT workflow on day one will be record. Suitability of patient set up and deliverability of dCT-RTplan will be documented as yes/no. Patient satisfaction will be assessed post treatment with a brief questionnaire and described using descriptive statistics. The carbon footprint saved by the dCT-RT method will be calculated by assessing the carbon footprint associated with travel from home (or hospital) to the cancer centre.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic CT | Experimental | Other: Diagnostic CTpatients will have their palliative radiotherapy designed on their diagnostic CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients >18 years of age
- Able to provide informed consent
- Patient able to lie supine comfortably
- Patient is receiving conventional palliative radiotherapy (Parallel Opposed Pair or single field over 8/1 or 20/5) for the treatment of bone metastases in the following locations: T5-lumbosacral spine, Bony pelvis
- Patient has a diagnostic CT scan which includes the anatomic location to be treated that is within 28 days of enrollment
Key exclusion criteria (7 listed)
- Patient unwilling, unable to consent to treatment/study
- Any contraindications to receiving radiotherapy including pregnancy
- Oncologic emergencies, on call treatments, or any indications for urgent radiotherapy
- Inability to comfortably maintain and immobilized position due to uncontrolled pain or co-morbidities
- Cases requiring VMAT planning or complex planning to account for prior courses of radiotherapy
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 CTradiotherapy will be designed on diagnostic CT. If plan is of sufficient quality, RT will be delivered to patient | Other | diagnostic CT |
Primary outcome
dosimetric accuracy of palliative radiotherapy designed on a dCT compared to a CT simulation
Time frame: 1 Year
assess suitability of patient set up using surface landmarks and kilo voltage (kV) imaging
Time frame: 1 Year
determine the proportion of patients who can receive radiotherapy designed on a dCT
Time frame: 1 Year
confirm eligibility criteria for appropriate patients in clinical practice
Time frame: 1 Year
2 secondary outcomes
patient satisfaction with treatment process
Time frame: 1 Year
evaluate carbon footprint savings of dCT-RT workflow
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic CT in people with Bone Metastases, run by British Columbia Cancer Agency.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shilo Lefresne, MD FRCPC (6048776000, SLefresne@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dosimetric accuracy of palliative radiotherapy designed on a dCT compared to a CT simulation (time frame: 1 Year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.