Prostate CancerC-armNCT02322931
C-arm Cone-beam CT in Prostate Brachytherapy
A study testing Intra-operative C-arm CT imaging in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Intra-operative C-arm CT imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Dec 2019
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- They are unable to undergo general or spinal anesthesia
- They are on anticoagulation therapy (blood thinners)
- They have had previous radiotherapy to the pelvis
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Sunshine Purificacion, MSc, 604-877-6000 ext. 2683, sunshine.purificacion@bccancer.bc.ca
William J Morris, MD
About this study
Official title: Intra-operative Use of C-arm Cone-beam CT for Quality Assurance of Low-dose-rate Prostate Brachytherapy Dose Delivery
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.
Read the 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
- Conditions
- Prostate Cancer
- Being tested
- Intra-operative C-arm CT imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative C-arm CT imagingProcedure or surgery
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Imaging interventions | Experimental | 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. Receives: Procedure: Intra-operative C-arm CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
Seed and boundary detection
To determine if Sagittal TRUS imaging provides better seed and boundary detection for dosimetric purposes compared to transverse imaging
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William J Morris, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322931
- Sponsor's protocol ID
- H14-02658
- Acronym
- C-arm
- Status last verified
- Jan 2018
- First submitted
- 12 Dec 2014
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Blasko JC, Mate T, Sylvester JE, Grimm PD, Cavanagh W. Brachytherapy for carcinoma of the prostate: techniques, patient selection, and clinical outcomes. Semin Radiat Oncol. 2002 Jan;12(1):81-94. doi: 10.1053/srao.2002.28667.
PubMed 11813153Chng 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.
PubMed 21361201Dubois DF, Prestidge BR, Hotchkiss LA, Prete JJ, Bice WS Jr. Intraobserver and interobserver variability of MR imaging- and CT-derived prostate volumes after transperineal interstitial permanent prostate brachytherapy. Radiology. 1998 Jun;207(3):785-9. doi: 10.1148/radiology.207.3.9609905.
PubMed 9609905Mahdavi 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.
PubMed 21084216Mahdavi 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.
PubMed 21944824Moradi M, Mahdavi SS, Dehghan E, Lobo JR, Deshmukh S, Morris WJ, Fichtinger G, Salcudean ST. Seed localization in ultrasound and registration to C-arm fluoroscopy using matched needle tracks for prostate brachytherapy. IEEE Trans Biomed Eng. 2012 Sep;59(9):2558-67. doi: 10.1109/TBME.2012.2206808. Epub 2012 Jun 29.
PubMed 22759435Morris WJ, Keyes M, Spadinger I, Kwan W, Liu M, McKenzie M, Pai H, Pickles T, Tyldesley S. Population-based 10-year oncologic outcomes after low-dose-rate brachytherapy for low-risk and intermediate-risk prostate cancer. Cancer. 2013 Apr 15;119(8):1537-46. doi: 10.1002/cncr.27911. Epub 2012 Dec 26.
PubMed 23280183Narayana V, Roberson PL, Pu AT, Sandler H, Winfield RH, McLaughlin PW. Impact of differences in ultrasound and computed tomography volumes on treatment planning of permanent prostate implants. Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):1181-5. doi: 10.1016/s0360-3016(96)00618-9.
PubMed 9169829Nath R, Bice WS, Butler WM, Chen Z, Meigooni AS, Narayana V, Rivard MJ, Yu Y; American Association of Physicists in Medicine. AAPM recommendations on dose prescription and reporting methods for permanent interstitial brachytherapy for prostate cancer: report of Task Group 137. Med Phys. 2009 Nov;36(11):5310-22. doi: 10.1118/1.3246613.
PubMed 19994539Roach M 3rd, Faillace-Akazawa P, Malfatti C, Holland J, Hricak H. Prostate volumes defined by magnetic resonance imaging and computerized tomographic scans for three-dimensional conformal radiotherapy. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):1011-8. doi: 10.1016/0360-3016(96)00232-5.
PubMed 8751410Smith WL, Lewis C, Bauman G, Rodrigues G, D'Souza D, Ash R, Ho D, Venkatesan V, Downey D, Fenster A. Prostate volume contouring: a 3D analysis of segmentation using 3DTRUS, CT, and MR. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1238-47. doi: 10.1016/j.ijrobp.2006.11.027.
PubMed 17336224Bice WS Jr, Prestidge BR, Grimm PD, Friedland JL, Feygelman V, Roach M 3rd, Prete JJ, Dubois DF, Blasko JC. Centralized multiinstitutional postimplant analysis for interstitial prostate brachytherapy. Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):921-7. doi: 10.1016/s0360-3016(98)90123-7.
PubMed 9652858
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Use of C-arm Cone-beam CT for Quality Assurance of Low-dose-rate Prostate Brachytherapy Dose Delivery
- ClinicalTrials.gov ID
- NCT02322931
- Acronym / sponsor ID
- C-arm / H14-02658
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging interventions | Experimental | Procedure: Intra-operative C-arm CT imagingEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- They are unable to undergo general or spinal anesthesia
- They are on anticoagulation therapy (blood thinners)
- They have had previous radiotherapy to the pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-operative C-arm CT imaging1. 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. 2. 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. 3. One Cine loop C-arm scan in the sagittal plane while retracting the probe. 4. 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). | Procedure or surgery | Imaging interventions |
Primary outcome
Dosimetric accuracy
Time frame: 12 months
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
2 secondary outcomes
Dosimetric values
Time frame: 12 months
Seed and boundary detection
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Background: PubMed 11813153Blasko JC, Mate T, Sylvester JE, Grimm PD, Cavanagh W. Brachytherapy for carcinoma of the prostate: techniques, patient selection, and clinical outcomes. Semin Radiat Oncol. 2002 Jan;12(1):81-94. doi: 10.1053/srao.2002.28667.
- Background: PubMed 21361201Chng 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.
- Background: PubMed 9609905Dubois DF, Prestidge BR, Hotchkiss LA, Prete JJ, Bice WS Jr. Intraobserver and interobserver variability of MR imaging- and CT-derived prostate volumes after transperineal interstitial permanent prostate brachytherapy. Radiology. 1998 Jun;207(3):785-9. doi: 10.1148/radiology.207.3.9609905.
- Background: PubMed 21084216Mahdavi 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.
- Background: PubMed 21944824Mahdavi 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.
- Background: PubMed 22759435Moradi M, Mahdavi SS, Dehghan E, Lobo JR, Deshmukh S, Morris WJ, Fichtinger G, Salcudean ST. Seed localization in ultrasound and registration to C-arm fluoroscopy using matched needle tracks for prostate brachytherapy. IEEE Trans Biomed Eng. 2012 Sep;59(9):2558-67. doi: 10.1109/TBME.2012.2206808. Epub 2012 Jun 29.
- Background: PubMed 23280183Morris WJ, Keyes M, Spadinger I, Kwan W, Liu M, McKenzie M, Pai H, Pickles T, Tyldesley S. Population-based 10-year oncologic outcomes after low-dose-rate brachytherapy for low-risk and intermediate-risk prostate cancer. Cancer. 2013 Apr 15;119(8):1537-46. doi: 10.1002/cncr.27911. Epub 2012 Dec 26.
- Background: PubMed 9169829Narayana V, Roberson PL, Pu AT, Sandler H, Winfield RH, McLaughlin PW. Impact of differences in ultrasound and computed tomography volumes on treatment planning of permanent prostate implants. Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):1181-5. doi: 10.1016/s0360-3016(96)00618-9.
- Background: PubMed 19994539Nath R, Bice WS, Butler WM, Chen Z, Meigooni AS, Narayana V, Rivard MJ, Yu Y; American Association of Physicists in Medicine. AAPM recommendations on dose prescription and reporting methods for permanent interstitial brachytherapy for prostate cancer: report of Task Group 137. Med Phys. 2009 Nov;36(11):5310-22. doi: 10.1118/1.3246613.
- Background: PubMed 8751410Roach M 3rd, Faillace-Akazawa P, Malfatti C, Holland J, Hricak H. Prostate volumes defined by magnetic resonance imaging and computerized tomographic scans for three-dimensional conformal radiotherapy. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):1011-8. doi: 10.1016/0360-3016(96)00232-5.
- Background: PubMed 17336224Smith WL, Lewis C, Bauman G, Rodrigues G, D'Souza D, Ash R, Ho D, Venkatesan V, Downey D, Fenster A. Prostate volume contouring: a 3D analysis of segmentation using 3DTRUS, CT, and MR. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1238-47. doi: 10.1016/j.ijrobp.2006.11.027.
- Background: PubMed 9652858Bice WS Jr, Prestidge BR, Grimm PD, Friedland JL, Feygelman V, Roach M 3rd, Prete JJ, Dubois DF, Blasko JC. Centralized multiinstitutional postimplant analysis for interstitial prostate brachytherapy. Int J Radiat Oncol Biol Phys. 1998 Jul 1;41(4):921-7. doi: 10.1016/s0360-3016(98)90123-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Morris, MD principal investigator
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative C-arm CT imaging in people with Prostate Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
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 5 inclusion and 3 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lorenz Yeung (604-87-6000 ext. 2683, Lorenz.Yeung@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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02322931, which also lists 12 linked publications.
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 18 Jan 2018.