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Not yet recruitingNCT06235034dCT-PRTUpdated Jan 31, 2024

Diagnostic CT Palliative Radiotherapy: Feasibility Study of Treating Bone Metastases Without a CT Simulation

An interventional study of Diagnostic CT in Bone Metastases, sponsored by British Columbia Cancer Agency. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by British Columbia Cancer Agency · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Bone Metastases

Keywords

  • Palliative Radiation
  • CT Simulation
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 10 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    diagnostic CT

    patients will have their palliative radiotherapy designed on their diagnostic CT

    Other: Diagnostic CT

Interventions

  • OtherDiagnostic CT

    radiotherapy will be designed on diagnostic CT. If plan is of sufficient quality, RT will be delivered to patient

06

What researchers measure

Primary outcomes

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

    Time frame: 1 Year

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

    Time frame: 1 Year

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

    Time frame: 1 Year

  4. confirm eligibility criteria for appropriate patients in clinical practice

    Time frame: 1 Year

Secondary outcomes

  1. patient satisfaction with treatment process

    Time frame: 1 Year

  2. evaluate carbon footprint savings of dCT-RT workflow

    Time frame: 1 Year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06235034
Lead sponsor
British Columbia Cancer Agency
Responsible party
Sponsor
First posted
Jan 31, 2024
Start date
Jan 20, 2024 (estimated)
Primary completion
Nov 30, 2024 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Jan 31, 2024

Study contacts

Shilo Lefresne, MD FRCPC
Contact
SLefresne@bccancer.bc.ca
6048776000
Sandy Chang
Contact
Sandy.Chang@bccancer.bc.ca
6048776000

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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