C-arm Cone-beam CT in Prostate Brachytherapy (C-arm)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intra-operative C-arm CT imaging
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Must be 18 years of age or older
- Must be able to give informed consent
- Must have been diagnosed with prostate cancer, as determined by a prostate biopsy
- Must not have had any prior history of cancer. Participants that have had some types of skins cancer are still able to participate
- Must be eligible for and receiving low-dose-rate prostate brachytherapy
Exclusion Criteria:
- They are unable to undergo general or spinal anesthesia
- They are on anticoagulation therapy (blood thinners)
- They have had previous radiotherapy to the pelvis
Sites / Locations
- British Columbia Cancer AgencyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imaging interventions
Arm Description
Eligible patients who consent to participate in this study will undergo a combination of 4 different imaging interventions (based on the group they're in, as described in the protocol), intra-operatively, in addition to their standard LDR brachytherapy treatment.
Outcomes
Primary Outcome Measures
Dosimetric accuracy
To determine if the intraoperative use of 3D C-arm cone-beam CT can eliminate the need for D-0 Ct for post-implant dosimetry in prostate LDR brachytherapy by providing similar or improved dosimetric accuracy
Secondary Outcome Measures
Dosimetric values
To determine if the dosimetric values obtained with the TRUS probe inside the rectum are significantly different from those measured when the probe is outside the rectum
Seed and boundary detection
To determine if Sagittal TRUS imaging provides better seed and boundary detection for dosimetric purposes compared to transverse imaging
Full Information
NCT ID
NCT02322931
First Posted
December 12, 2014
Last Updated
January 16, 2018
Sponsor
British Columbia Cancer Agency
1. Study Identification
Unique Protocol Identification Number
NCT02322931
Brief Title
C-arm Cone-beam CT in Prostate Brachytherapy
Acronym
C-arm
Official Title
Intra-operative Use of C-arm Cone-beam CT for Quality Assurance of Low-dose-rate Prostate Brachytherapy Dose Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators will assess the feasibility of intraoperative use of C-arm cone-beam CT imaging for intraoperative dosimetric evaluation in prostate low-dose-rate (LDR) brachytherapy. Patients recruited are those who will receive standard LDR brachytherapy for prostate cancer treatment. Consenting patients will undergo additional 3D C-arm cone-beam CT imaging (3D C-arm) and motorized trans-rectal ultrasound (TRUS). Volumetric and dosimetric measures will be compared to those using the standard Day-0 CT images. The investigators hope that the intraoperative 3D C-arm provides quality assurance measures sufficient to eliminate the need for Day-0 CT LDR brachytherapy and provide the opportunity for intraoperative modification of seed delivery plan.
Detailed Description
Objectives
The primary objective of this study is to determine the feasibility of replacing Day-0 CT with intra-operative 3D C-arm imaging. The main benefit of this change is to receive immediate feedback on the quality of treatment. This can lead to the possibility of performing "live" adjustments to the treatment plan based on feedback of actual seed positions achieved after implantation.
Secondly, by replacing Day-0 CT, a separate scan performed in a different site will be eliminated from the treatment procedure, freeing up the CT scanner for other clinical uses
Hypotheses
Primary hypothesis: Intraoperative use of 3D C-arm cone-beam CT can eliminate the need for Day-0 CT for post-implant dosimetry in prostate LDR brachytherapy by providing similar or improved dosimetric accuracy
Secondary hypothesis 1: Dosimetric values obtained with the TRUS probe inside the rectum are not significantly different from those measured when the probe is outside the rectum
Secondary hypothesis 2: Sagittal TRUS imaging provides better seed and boudnary detection for dosimetric purposes compared to transverse imaging
Justification
Standard post-implant quality assessment at the BC Cancer Agency involves a pelvic CT 2-3 hours after treatment. This scan is performed outside the operating room, in a different location. As a result, it is not possible to receive immediate feedback on the quality of treatment. Furthermore, soft tissue visualization is poor in CT imaging and contouring variability is large. The use of other imaging modalities such as ultrasound would be beneficial. However, since the scan is performed at a different time, and with the patient in a different position, registering the images would be challenging.
Intra-operative C-arm CT imaging would provide immediate feedback on the quality of treatment, provide the opportunity of using information from intra-operative ultrasound imaging for soft tissue visualization, and eliminate the need for a separate scan in a different location.
Research method
Patients who are receiving low-dose-rate brachytherapy and consent to participate will undergo the additional imaging interventions described in section 5.7 of the application.
Patients will also undergo a pelvic CT as the standard of care.
To limit patient exposure to additional radiation dose, the investigators will divide the participants into 3 groups, each of which will receive a portion of the abovementioned scans. Details are described in the attached protocol.
Seed locations will be identified on the 3D C-arm volume. The prostate volume on the TRUS images will be delineated and the contours will be mapped onto the 3D C-arm volume to compute standard dosimetric parameters (V100, D90). Seeds and contours will be outlined on the corresponding Day-0 CT and standard dosimetric parameters will be computed. Day-0 CT will be contoured by multiple observers to compute variability in the resulting dosimetric parameters. Dosimetric values from the 3D C-arm will be compared to those of Day-0 CT and their intra-observer variability.
The seeds will be identified on 3D C-arm volumes with the TRUS probe inserted and retracted to create two seed clouds. Corresponding seeds will be matched. The difference between the seed locations in the two seed clouds will be used to model the prostate deformation due to the presence and absence of the TRUS probe.
Statistical analysis This is mainly a descriptive one-arm study. No comparative statistical tests will be applied
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imaging interventions
Arm Type
Experimental
Arm Description
Eligible patients who consent to participate in this study will undergo a combination of 4 different imaging interventions (based on the group they're in, as described in the protocol), intra-operatively, in addition to their standard LDR brachytherapy treatment.
Intervention Type
Procedure
Intervention Name(s)
Intra-operative C-arm CT imaging
Intervention Description
Two intra-operative C-arm 3D reconstruction scans with the Ziehm Vision FD Vario 3D immediately after treatment implantation, once with the TRUS probe inserted and once with the TRUS probe removed. This involves approximately 10 fluoroscopy snapshots of the prostate.
Two TRUS Sagittal B-mode sweeps and two TRUS axial B-mode sweeps, once mid-way, i.e. after implanting a sub-set of the seeds, and once at the end of the implantation procedure.
One Cine loop C-arm scan in the sagittal plane while retracting the probe.
One 3D C-arm scan immediately after the treatment, with the TRUS probe removed and the patient in the supine position (i.e. legs down).
Primary Outcome Measure Information:
Title
Dosimetric accuracy
Description
To determine if the intraoperative use of 3D C-arm cone-beam CT can eliminate the need for D-0 Ct for post-implant dosimetry in prostate LDR brachytherapy by providing similar or improved dosimetric accuracy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Dosimetric values
Description
To determine if the dosimetric values obtained with the TRUS probe inside the rectum are significantly different from those measured when the probe is outside the rectum
Time Frame
12 months
Title
Seed and boundary detection
Description
To determine if Sagittal TRUS imaging provides better seed and boundary detection for dosimetric purposes compared to transverse imaging
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be 18 years of age or older
Must be able to give informed consent
Must have been diagnosed with prostate cancer, as determined by a prostate biopsy
Must not have had any prior history of cancer. Participants that have had some types of skins cancer are still able to participate
Must be eligible for and receiving low-dose-rate prostate brachytherapy
Exclusion Criteria:
They are unable to undergo general or spinal anesthesia
They are on anticoagulation therapy (blood thinners)
They have had previous radiotherapy to the pelvis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenz Yeung
Phone
604-87-6000
Ext
2683
Email
Lorenz.Yeung@bccancer.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Morris, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunshine Purificacion, MSc
Phone
604-877-6000
Ext
2683
Email
sunshine.purificacion@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
William J Morris, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
11813153
Citation
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Results Reference
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21361201
Citation
Chng N, Spadinger I, Morris WJ, Usmani N, Salcudean S. Prostate brachytherapy postimplant dosimetry: automatic plan reconstruction of stranded implants. Med Phys. 2011 Jan;38(1):327-42. doi: 10.1118/1.3525839.
Results Reference
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PubMed Identifier
9609905
Citation
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Results Reference
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PubMed Identifier
21084216
Citation
Mahdavi SS, Chng N, Spadinger I, Morris WJ, Salcudean SE. Semi-automatic segmentation for prostate interventions. Med Image Anal. 2011 Apr;15(2):226-37. doi: 10.1016/j.media.2010.10.002. Epub 2010 Oct 26.
Results Reference
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PubMed Identifier
21944824
Citation
Mahdavi SS, Spadinger I, Chng N, Salcudean SE, Morris WJ. Semiautomatic segmentation for prostate brachytherapy: dosimetric evaluation. Brachytherapy. 2013 Jan-Feb;12(1):65-76. doi: 10.1016/j.brachy.2011.07.007. Epub 2011 Sep 25.
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PubMed Identifier
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Citation
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Citation
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C-arm Cone-beam CT in Prostate Brachytherapy
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