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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Shilo Lefresne, MD FRCPC contact

6048776000

SLefresne@bccancer.bc.ca

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 groups in NCT06235034
Study groupRoleWhat they receive
diagnostic CTExperimentalpatients 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.

  1. dosimetric accuracy of palliative radiotherapy designed on a dCT compared to a CT simulation

    Measured: 1 Year

  2. assess suitability of patient set up using surface landmarks and kilo voltage (kV) imaging

    Measured: 1 Year

  3. determine the proportion of patients who can receive radiotherapy designed on a dCT

    Measured: 1 Year

  4. confirm eligibility criteria for appropriate patients in clinical practice

    Measured: 1 Year

Secondary outcomes (2)
  1. patient satisfaction with treatment process

    Measured: 1 Year

  2. 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.

  1. First posted31 Jan 2024
  2. Study start20 Jan 2024 (estimated)
  3. Primary completion30 Nov 2024 (estimated)
  4. Study completion30 Apr 2025 (estimated)

Resources

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)
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

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.

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