NCT06235034

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

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

December 21, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

January 31, 2024

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 21, 2023

Last Update Submit

January 22, 2024

Conditions

Keywords

Palliative RadiationCT Simulation

Outcome Measures

Primary Outcomes (4)

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

    1 Year

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

    1 Year

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

    1 Year

  • confirm eligibility criteria for appropriate patients in clinical practice

    1 Year

Secondary Outcomes (2)

  • patient satisfaction with treatment process

    1 Year

  • evaluate carbon footprint savings of dCT-RT workflow

    1 Year

Study Arms (1)

diagnostic CT

EXPERIMENTAL

patients will have their palliative radiotherapy designed on their diagnostic CT

Other: Diagnostic CT

Interventions

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

diagnostic CT

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Shilo Lefresne, MD FRCPC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 31, 2024

Study Start

January 20, 2024

Primary Completion

November 30, 2024

Study Completion

April 30, 2025

Last Updated

January 31, 2024

Record last verified: 2023-12