Prostatic NeoplasmsPhase 1NCT02233725
MRI / Ultrasound Fusion With Contrast-Enhanced Ultrasound Guidance
A Phase 1 study testing Definity Perflutren Injectable Suspension in people with Prostatic Neoplasms, run by University of British Columbia at 1 site in Canada.
Trial summary
Prostate cancer is the most common cancer in men. It is most often detected by an abnormal digital rectal exam or an elevated Prostate-Specific Antigen -determine by a blood test. When it is suspected that someone may have prostate cancer, a biopsy is ordered. Read more about this study
- Who is it for?
- Ages 25 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Definity Perflutren Injectable Suspension
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Dec 2015
- Phase
- Phase 1
- 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 25 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ( aged 21 years or greater), English speaking patients
Who cannot join
- Patients who are unable to provide informed consent
- Patients who have had previous reaction to any contrast agent at any point in the past
- Patients who have had previous septic infection from prostate biopsies at any point in the past
- Patients who have a right-to-left, bi-directional, or transient right-to-left cardiac shunts.
- Patients undergoing extracorporeal shock wave lithotripsy for urinary calculi.
- Patients with pre-existing cardiopulmonary compromise including, but not limited to, acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver Coastal Health (VCHRI/VCHA)
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Pilot-Study - Incorporating Contrast-Enhanced Ultrasound (CEUS) to Real-Tim MRI / Ultrasound Fusion Imaging for Prostate Biopsies
Prostate cancer is the most common cancer in men. It is most often detected by an abnormal digital rectal exam or an elevated Prostate-Specific Antigen -determine by a blood test. When it is suspected that someone may have prostate cancer, a biopsy is ordered. This biopsy is performed by the Radiologist with ultrasound guidance through the rectum. In some patients, a Magnetic Resonance Imaging (MRI) scan of the prostate may be ordered to further evaluate the prostate. In some situations, the MRI and Ultrasound images will be fused (digitally merged) together during the ultrasound procedure to help localize the questionable lesions. Recent research has used an additional component known as a contrast agent - an intravenously injected inert substance - which is identifiable by ultrasound. This inert substance is more obvious in areas of increased blood flow, which is a common finding in cancerous lesions. In this research project, we would like to determine whether the use of contrast-enhanced ultrasound is beneficial in improving accuracy of the biopsies taken and the relative correlation to the MRI/ Ultrasound-fused images.
Read the detailed description
It is the hypothesis that cancerous lesions in the prostate will have an increased amount of blood flow, and that the lesions identified under ultrasound with the benefits of contrast-enhanced imaging can be correlated to the MRI Findings in real-time. A study of 50 patients who would be undergoing MRI/Ultrasound fusion would be selected to have contrast added to their procedure. The lesions identified on MRI would then be evaluated with contrast-enhanced ultrasound. The findings from the contrast study could then be correlated with the MRI findings. The rest of the prostate gland would also be assessed using the contrast agent for lesions not identified on the MRI imaging study. The pathology results could be correlated with both the contrast study and the MRI study both independently, and in conjunction with the two imaging modalities. If a correlation between highly suspicious lesions on the MRI and significant flow patterns under contrast can be established, then the sensitivity and specificity of contrast-enhanced ultrasound can be increased.
While MRI / Ultrasound Fusion is being shown to increase prostate cancer identification and targeting for biopsy, it is a very limited modality due to the costs associated. Many sites will also not have access to an MRI unit, and the fusion system is prohibitively expensive, and requires specialized training to configure the system and modulate the images in real-time. However, ultrasound is an in expensive modality that is readily available. If the materials and methods in the utilization of contrast-enhanced ultrasounds can be correlated to MRI / Ultrasound fusion, better protocols can be developed for contrast-enhanced ultrasound. This more cost-effective method of identifying and targeting prostate cancer could then be exported to smaller communities who would otherwise still be carrying out the sextant biopsy model.
- Conditions
- Prostatic Neoplasms
- Being tested
- Definity Perflutren Injectable Suspension
- Keywords
- Prostatic Neoplasms, Magnetic Resonance Imaging, MRI / Ultrasound Fusion, Contrast-Enhanced Ultrasound (CEUS)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definity Perflutren Injectable SuspensionDevice
Also called Lantheus DEFINITY, FDA Application No. - (NDA) 021064, Active Ingredient(s) - PERFLUTREN, Strength- 6.52MG/ML
a single dose of 10 μL/kg of the activated product by intravenous bolus injection over 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 μL/kg dose may be administered 5 minutes after the first injection to prolong contrast enhancement
| Study group | Role | What they receive |
|---|---|---|
| Definity Perflutren Suspension | Active comparator | Injection of Definity Perflutren Injectable Suspension- which travels in the bloodstream throughout the body. These microbubbles are identifiable on ultrasound imaging, and studies of the liver and kidney have identified it as a useful adjunct to identifying vascular lesions. Areas of regular blood flow will not have as large a concentration of the microbubble agent as will areas that have increased blood flow and neovascularisation. It has been well documented that cancerous solid lesions undergo neovascularisation and have increased blood flow to the area. Receives: Device: Definity Perflutren Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the quality and pathology results of prostate samples taken during Contrast-Enhanced Ultrasound (CEUS) with MRI/ Ultrasound fusion.
It is hypothesized that the introduction of the Definity contrast agent during the ultrasound biopsy will increase the accuracy of the targeting biopsy sample, as well as reduce the number of targeted biopsies of non-cancerous lesions. We will compare the MRI characteristics of the prostate lesions in question in real-time ( as the MRI and Ultrasound will be fused together ), and determine whether questionable lesions seen under MRI have increased flow dynamics
Measured: 1 Day
Secondary outcomes (1)
Measure whether the use of Contrast-Enhanced Ultrasound (CEUS) on prostate cancer detection rates when incorporated with MRI / Ultrasound Fusion differs from non-CEUS prostate biopsies performed under MRI/ Ultrasound Fusion guidance
We will measure the number of prostate samples that are determined to be positive for prostate cancer, and compare that with a control group with similar prostate characteristic appearances.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Eddy, BSc, Study director, VCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233725
- Sponsor's protocol ID
- H14-00830
- Status last verified
- Sep 2014
- First submitted
- 28 Aug 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Maxeiner A, Fischer T, Stephan C, Cash H, Slowinski T, Kilic E, Durmus T. [Real-time MRI/US fusion-guided biopsy improves detection rates of prostate cancer in pre-biopsied patients]. Aktuelle Urol. 2014 May;45(3):197-203. doi: 10.1055/s-0034-1375682. Epub 2014 Jun 5. German.
PubMed 24902069Rifkin MD, Dahnert W, Kurtz AB. State of the art: endorectal sonography of the prostate gland. AJR Am J Roentgenol. 1990 Apr;154(4):691-700. doi: 10.2214/ajr.154.4.1690499. No abstract available.
PubMed 1690499Oyen R, Van Popel H, Van de Voorde W, Knapen P, Ameye F, Baert AL, Baert LV. [The significance of focal hypoechoic lesions in the peripheral zone of the prostate]. J Belge Radiol. 1995 Dec;78(6):356-8. Dutch.
PubMed 8576025Sibley RI, Sibley AF. Correlation of digital rectal examination, prostate specific antigen, and transrectal ultrasound in prostate carcinoma in African Americans. J Natl Med Assoc. 1997 May;89(5):318-23.
PubMed 9170832Norberg M, Egevad L, Holmberg L, Sparen P, Norlen BJ, Busch C. The sextant protocol for ultrasound-guided core biopsies of the prostate underestimates the presence of cancer. Urology. 1997 Oct;50(4):562-6. doi: 10.1016/S0090-4295(97)00306-3.
PubMed 9338732Halpern EJ, Ramey JR, Strup SE, Frauscher F, McCue P, Gomella LG. Detection of prostate carcinoma with contrast-enhanced sonography using intermittent harmonic imaging. Cancer. 2005 Dec 1;104(11):2373-83. doi: 10.1002/cncr.21440.
PubMed 16240450Mitterberger M, Pinggera GM, Horninger W, Bartsch G, Strasser H, Schafer G, Brunner A, Halpern EJ, Gradl J, Pallwein L, Frauscher F. Comparison of contrast enhanced color Doppler targeted biopsy to conventional systematic biopsy: impact on Gleason score. J Urol. 2007 Aug;178(2):464-8; discussion 468. doi: 10.1016/j.juro.2007.03.107. Epub 2007 Jun 11.
PubMed 17561137
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Study - Incorporating Contrast-Enhanced Ultrasound (CEUS) to Real-Tim MRI / Ultrasound Fusion Imaging for Prostate Biopsies
- ClinicalTrials.gov ID
- NCT02233725
- Acronym / sponsor ID
- H14-00830
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostatic Neoplasms, Magnetic Resonance Imaging, MRI / Ultrasound Fusion, Contrast-Enhanced Ultrasound (CEUS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 8 Sep 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.
Prostate cancer is the most common cancer in men. It is most often detected by an abnormal digital rectal exam or an elevated Prostate-Specific Antigen -determine by a blood test. When it is suspected that someone may have prostate cancer, a biopsy is ordered. This biopsy is performed by the Radiologist with ultrasound guidance through the rectum. In some patients, a Magnetic Resonance Imaging (MRI) scan of the prostate may be ordered to further evaluate the prostate. In some situations, the MRI and Ultrasound images will be fused (digitally merged) together during the ultrasound procedure to help localize the questionable lesions. Recent research has used an additional component known as a contrast agent - an intravenously injected inert substance - which is identifiable by ultrasound. This inert substance is more obvious in areas of increased blood flow, which is a common finding in cancerous lesions. In this research project, we would like to determine whether the use of contrast-enhanced ultrasound is beneficial in improving accuracy of the biopsies taken and the relative correlation to the MRI/ Ultrasound-fused images.
Detailed description
It is the hypothesis that cancerous lesions in the prostate will have an increased amount of blood flow, and that the lesions identified under ultrasound with the benefits of contrast-enhanced imaging can be correlated to the MRI Findings in real-time. A study of 50 patients who would be undergoing MRI/Ultrasound fusion would be selected to have contrast added to their procedure. The lesions identified on MRI would then be evaluated with contrast-enhanced ultrasound. The findings from the contrast study could then be correlated with the MRI findings. The rest of the prostate gland would also be assessed using the contrast agent for lesions not identified on the MRI imaging study. The pathology results could be correlated with both the contrast study and the MRI study both independently, and in conjunction with the two imaging modalities. If a correlation between highly suspicious lesions on the MRI and significant flow patterns under contrast can be established, then the sensitivity and specificity of contrast-enhanced ultrasound can be increased.
While MRI / Ultrasound Fusion is being shown to increase prostate cancer identification and targeting for biopsy, it is a very limited modality due to the costs associated. Many sites will also not have access to an MRI unit, and the fusion system is prohibitively expensive, and requires specialized training to configure the system and modulate the images in real-time. However, ultrasound is an in expensive modality that is readily available. If the materials and methods in the utilization of contrast-enhanced ultrasounds can be correlated to MRI / Ultrasound fusion, better protocols can be developed for contrast-enhanced ultrasound. This more cost-effective method of identifying and targeting prostate cancer could then be exported to smaller communities who would otherwise still be carrying out the sextant biopsy model.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Definity Perflutren Suspension | Active comparator | Device: Definity Perflutren Injectable SuspensionInjection of Definity Perflutren Injectable Suspension- which travels in the bloodstream throughout the body. These microbubbles are identifiable on ultrasound imaging, and studies of the liver and kidney have identified it as a useful adjunct to identifying vascular lesions. Areas of regular blood flow will not have as large a concentration of the microbubble agent as will areas that have increased blood flow and neovascularisation. It has been well documented that cancerous solid lesions undergo neovascularisation and have increased blood flow to the area. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults ( aged 21 years or greater), English speaking patients
Key exclusion criteria (6 listed)
- Patients who are unable to provide informed consent
- Patients who have had previous reaction to any contrast agent at any point in the past
- Patients who have had previous septic infection from prostate biopsies at any point in the past
- Patients who have a right-to-left, bi-directional, or transient right-to-left cardiac shunts.
- Patients undergoing extracorporeal shock wave lithotripsy for urinary calculi.
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 |
|---|---|---|
| Definity Perflutren Injectable SuspensionAlso: Lantheus DEFINITY, FDA Application No. - (NDA) 021064, Active Ingredient(s) - PERFLUTREN, Strength- 6.52MG/MLa single dose of 10 μL/kg of the activated product by intravenous bolus injection over 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 μL/kg dose may be administered 5 minutes after the first injection to prolong contrast enhancement | Device | Definity Perflutren Suspension |
Primary outcome
Measure the quality and pathology results of prostate samples taken during Contrast-Enhanced Ultrasound (CEUS) with MRI/ Ultrasound fusion.
Time frame: 1 Day
It is hypothesized that the introduction of the Definity contrast agent during the ultrasound biopsy will increase the accuracy of the targeting biopsy sample, as well as reduce the number of targeted biopsies of non-cancerous lesions. We will compare the MRI characteristics of the prostate lesions in question in real-time ( as the MRI and Ultrasound will be fused together ), and determine whether questionable lesions seen under MRI have increased flow dynamics
1 secondary outcome
Measure whether the use of Contrast-Enhanced Ultrasound (CEUS) on prostate cancer detection rates when incorporated with MRI / Ultrasound Fusion differs from non-CEUS prostate biopsies performed under MRI/ Ultrasound Fusion guidance
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Background: PubMed 24902069Maxeiner A, Fischer T, Stephan C, Cash H, Slowinski T, Kilic E, Durmus T. [Real-time MRI/US fusion-guided biopsy improves detection rates of prostate cancer in pre-biopsied patients]. Aktuelle Urol. 2014 May;45(3):197-203. doi: 10.1055/s-0034-1375682. Epub 2014 Jun 5. German.
- Background: PubMed 1690499Rifkin MD, Dahnert W, Kurtz AB. State of the art: endorectal sonography of the prostate gland. AJR Am J Roentgenol. 1990 Apr;154(4):691-700. doi: 10.2214/ajr.154.4.1690499. No abstract available.
- Background: PubMed 8576025Oyen R, Van Popel H, Van de Voorde W, Knapen P, Ameye F, Baert AL, Baert LV. [The significance of focal hypoechoic lesions in the peripheral zone of the prostate]. J Belge Radiol. 1995 Dec;78(6):356-8. Dutch.
- Background: PubMed 9170832Sibley RI, Sibley AF. Correlation of digital rectal examination, prostate specific antigen, and transrectal ultrasound in prostate carcinoma in African Americans. J Natl Med Assoc. 1997 May;89(5):318-23.
- Background: PubMed 9338732Norberg M, Egevad L, Holmberg L, Sparen P, Norlen BJ, Busch C. The sextant protocol for ultrasound-guided core biopsies of the prostate underestimates the presence of cancer. Urology. 1997 Oct;50(4):562-6. doi: 10.1016/S0090-4295(97)00306-3.
- Background: PubMed 16240450Halpern EJ, Ramey JR, Strup SE, Frauscher F, McCue P, Gomella LG. Detection of prostate carcinoma with contrast-enhanced sonography using intermittent harmonic imaging. Cancer. 2005 Dec 1;104(11):2373-83. doi: 10.1002/cncr.21440.
- Background: PubMed 17561137Mitterberger M, Pinggera GM, Horninger W, Bartsch G, Strasser H, Schafer G, Brunner A, Halpern EJ, Gradl J, Pallwein L, Frauscher F. Comparison of contrast enhanced color Doppler targeted biopsy to conventional systematic biopsy: impact on Gleason score. J Urol. 2007 Aug;178(2):464-8; discussion 468. doi: 10.1016/j.juro.2007.03.107. Epub 2007 Jun 11.
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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.
Christopher Eddy, BSc study director
VCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Definity Perflutren Injectable Suspension in people with Prostatic Neoplasms, run by University of British Columbia 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 1 inclusion and 6 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 8 Sep 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the quality and pathology results of prostate samples taken during Contrast-Enhanced Ultrasound (CEUS) with MRI/ Ultrasound fusion. (time frame: 1 Day). 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 NCT02233725, which also lists 7 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 8 Sep 2014.