Clinical Trials Logo

Clinical 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). 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06235034
Study type Interventional
Source British Columbia Cancer Agency
Contact Shilo Lefresne, MD FRCPC
Phone 6048776000
Email SLefresne@bccancer.bc.ca
Status Not yet recruiting
Phase N/A
Start date January 20, 2024
Completion date April 30, 2025

See also
  Status Clinical Trial Phase
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Active, not recruiting NCT01996046 - FDG PET/CT in Breast Cancer Bone Mets
Completed NCT01358539 - Palliation: the Effect of Education on Pain Phase 3
Terminated NCT00981578 - ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain N/A
Terminated NCT00757757 - A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases Phase 1/Phase 2
Completed NCT00762346 - Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis Phase 4
Completed NCT00420433 - Bone Response in Metastatic Breast Cancer Involving Bones N/A
Completed NCT02826382 - Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041 Early Phase 1
Terminated NCT05301062 - A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
Recruiting NCT06367491 - National Database of Bone Metastases
Completed NCT03223727 - Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Completed NCT00830180 - Open Label Extension In Cancer Patients Phase 2
Active, not recruiting NCT03305224 - The Combination Therapy With Ra-223 and Enzalutamide Phase 2
Withdrawn NCT04109937 - External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial N/A
Active, not recruiting NCT02880943 - Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL) Phase 1/Phase 2
Completed NCT01696760 - Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology N/A
Completed NCT00958477 - A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer Phase 1
Completed NCT03979118 - Exercise Prescription in Patients With Bone Metastases
Completed NCT03353090 - Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients N/A
Recruiting NCT05167669 - Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU Early Phase 1