Prostate CancerNCT03091231
Multiparametric Ultrasound-Study for the Detection of Prostate Cancer
An observational study of Prostate Cancer, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
Trial summary
The primary objective of the study is the matching of sensitivity, specificity, the negative predicate value and the positive predictive value of Contrast-Enhanced Ultrasound (CEUS), Shear Wave Elastography (SWE) and the combination to detect clinically significant prostate carcinoma foki. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- mpUS multiparametric Ultrasound
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2017to 31 Mar 2018
- Phase
- Observational
- 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 to 75 years
- Men only
- Adult, Older adult
Study population: All patients scheduled for radical prostatectomy in the Martini Klinik that fulfil the inclusion criteria and do not have any of the exclusion criteria are eligible for participation in this study. Patients will be informed about the objectives, procedures and risks of the study all patients will have to sign written informed consent prior to participation.
Who may be able to join
- age ≥ 18 years
- signed informed consent
Who cannot join
- History of any clinically evidence of cardiac right-to-left shunts
- Receives treatment that includes dobutamine
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
- Is incapable of understanding the language in which the information for the patient is given
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiparametric Ultrasound - Contrast Enhanced Ultrasound and Shear Wave Elastography Compared to Radical Prostatectomy Specimens in 50 Patients
The primary objective of the study is the matching of sensitivity, specificity, the negative predicate value and the positive predictive value of Contrast-Enhanced Ultrasound (CEUS), Shear Wave Elastography (SWE) and the combination to detect clinically significant prostate carcinoma foki.
Conventional ultrasound is insufficient to safely display prostate carcinoma. Therefore, other imaging agents are recently added to improve the detection of tumor foci. These include innovative imaging ultrasound methods and multiparametric MRI.
Read the detailed description
All patients scheduled for radical prostatectomy in the Martini-Klinik are admitted the day prior to the surgery. In case a patient gives his informed consent mpUS (multiparametric Ultrasound) scanning is performed on the day prior to surgery, the day of admittance. The patient will be prepared with an intravenous access to administer the contrast agent. Ultrasound Scanning will be performed in the left-lateral decubitus position and start with regular B-mode scanning and volumetry. A base to apex sweeps and left to right sweep will be acquired to allow building a 3D reconstruction of the prostate. The imaging protocol will then start with SWE. Stiffness of the tissue is measured in Shear modulus (kPa) and visualized in a color scale. SWE results will be recorded for later interpretation and analysis. Then 2 minute recordings of CEUS imaging will be made following the administration of a 2.4ml bolus of the contrast agent SonoVue® (Bracco, Geneva) through the intravenous canula. A maximum of four recordings will be made. For every recording a new bolus of contrast agent will be administered. In this way, for planes the contrast inflow can be recorded. Data will be stored and transported to an image processing system for dispersion analysis. On this system a dispersion (CUDI) parametric map will be constructed from each acquired CEUS recording. At the time of interpretation imaging results will be scored separately for the standard prostate sextants, base left, base right, mid left, mid right, apex left and apex right.
The radical prostatectomy will be performed as in accordance to institution standards. This procedure will not be altered because of the trial. In many cases this means frozen sections are taken intraoperatively from the lateral sides of the prostate. These frozen sections are processed separately from the resection specimen in the pathology lab. Following the radical prostatectomy the resection specimen is fixated according to institution standards. This means that the specimen is photographed and the location and orientation of all coupes is recorded. This will enable allocating pathology findings to the standard prostate sextants described earlier.
- Conditions
- Prostate Cancer
- Being tested
- mpUS multiparametric Ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpUS multiparametric UltrasoundDiagnostic test
compare the mpUS to other methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy in terms of sensitivity and specificity of CEUS, SWE and their combination using radical prostatectomy specimens as the gold-standard.
The data gathered will be structured so that for each prostate sextant B-mode TRUS results, SWE results, CEUS results including CUDI maps and Pathology results are available for correlation. For the imaging modalities quantifiable data and visual interpretation using a 1 to 5 Likert-type scale for suspicion will be stored for each sextant. Pathology data will be gathered in the form of tumor size and grade. The data will be used to calculate sensitivity, specificity, negative predictive value and positive predictive value for each of the imaging modalities separately. Furthermore the data will be used to calculate an optimal algorithm for combining the imaging modalities. The maximum attainable sensitivity, specificity, NPV and PPV for tumor detection using this optimized algorithm will be calculated.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start15 May 2017
- Primary completion31 Dec 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martini-Klinik am UKE GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology
- Responsible party
- Sponsor
- Investigators
- Georg Salomon, PD Dr., Principal investigator, Martini-Klinik am UKE GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091231
- Sponsor's protocol ID
- mpUS-Study_2016
- Status last verified
- Apr 2023
- First submitted
- 14 Mar 2017
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data from ultrasound results and histological findings are sent to the TU Eindhoven in Eindhoven (Netherlands) for quantification analysis.
Publications
Mannaerts CK, Wildeboer RR, Postema AW, Hagemann J, Budaus L, Tilki D, Mischi M, Wijkstra H, Salomon G. Multiparametric ultrasound: evaluation of greyscale, shear wave elastography and contrast-enhanced ultrasound for prostate cancer detection and localization in correlation to radical prostatectomy specimens. BMC Urol. 2018 Nov 8;18(1):98. doi: 10.1186/s12894-018-0409-5.
PubMed 30409150
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Ultrasound - Contrast Enhanced Ultrasound and Shear Wave Elastography Compared to Radical Prostatectomy Specimens in 50 Patients
- ClinicalTrials.gov ID
- NCT03091231
- Acronym / sponsor ID
- mpUS-Study_2016
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Martini-Klinik am UKE GmbHUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology
- Study start
- 15 May 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 27 Mar 2017 (actual)
- 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 primary objective of the study is the matching of sensitivity, specificity, the negative predicate value and the positive predictive value of Contrast-Enhanced Ultrasound (CEUS), Shear Wave Elastography (SWE) and the combination to detect clinically significant prostate carcinoma foki.
Conventional ultrasound is insufficient to safely display prostate carcinoma. Therefore, other imaging agents are recently added to improve the detection of tumor foci. These include innovative imaging ultrasound methods and multiparametric MRI.
Detailed description
All patients scheduled for radical prostatectomy in the Martini-Klinik are admitted the day prior to the surgery. In case a patient gives his informed consent mpUS (multiparametric Ultrasound) scanning is performed on the day prior to surgery, the day of admittance. The patient will be prepared with an intravenous access to administer the contrast agent. Ultrasound Scanning will be performed in the left-lateral decubitus position and start with regular B-mode scanning and volumetry. A base to apex sweeps and left to right sweep will be acquired to allow building a 3D reconstruction of the prostate. The imaging protocol will then start with SWE. Stiffness of the tissue is measured in Shear modulus (kPa) and visualized in a color scale. SWE results will be recorded for later interpretation and analysis. Then 2 minute recordings of CEUS imaging will be made following the administration of a 2.4ml bolus of the contrast agent SonoVue® (Bracco, Geneva) through the intravenous canula. A maximum of four recordings will be made. For every recording a new bolus of contrast agent will be administered. In this way, for planes the contrast inflow can be recorded. Data will be stored and transported to an image processing system for dispersion analysis. On this system a dispersion (CUDI) parametric map will be constructed from each acquired CEUS recording. At the time of interpretation imaging results will be scored separately for the standard prostate sextants, base left, base right, mid left, mid right, apex left and apex right.
The radical prostatectomy will be performed as in accordance to institution standards. This procedure will not be altered because of the trial. In many cases this means frozen sections are taken intraoperatively from the lateral sides of the prostate. These frozen sections are processed separately from the resection specimen in the pathology lab. Following the radical prostatectomy the resection specimen is fixated according to institution standards. This means that the specimen is photographed and the location and orientation of all coupes is recorded. This will enable allocating pathology findings to the standard prostate sextants described earlier.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for radical prostatectomy in the Martini Klinik that fulfil the inclusion criteria and do not have any of the exclusion criteria are eligible for participation in this study. Patients will be informed about the objectives, procedures and risks of the study all patients will have to sign written informed consent prior to participation.
Key inclusion criteria (2 listed)
- age ≥ 18 years
- signed informed consent
Key exclusion criteria (5 listed)
- History of any clinically evidence of cardiac right-to-left shunts
- Receives treatment that includes dobutamine
- Severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study
- Is incapable of understanding the language in which the information for the patient is given
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 |
|---|---|---|
| mpUS multiparametric Ultrasoundcompare the mpUS to other methods | Diagnostic test | – |
Primary outcome
Diagnostic accuracy in terms of sensitivity and specificity of CEUS, SWE and their combination using radical prostatectomy specimens as the gold-standard.
Time frame: 14 days
The data gathered will be structured so that for each prostate sextant B-mode TRUS results, SWE results, CEUS results including CUDI maps and Pathology results are available for correlation. For the imaging modalities quantifiable data and visual interpretation using a 1 to 5 Likert-type scale for suspicion will be stored for each sextant. Pathology data will be gathered in the form of tumor size and grade. The data will be used to calculate sensitivity, specificity, negative predictive value and positive predictive value for each of the imaging modalities separately. Furthermore the data will be used to calculate an optimal algorithm for combining the imaging modalities. The maximum attainable sensitivity, specificity, NPV and PPV for tumor detection using this optimized algorithm will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 30409150Mannaerts CK, Wildeboer RR, Postema AW, Hagemann J, Budaus L, Tilki D, Mischi M, Wijkstra H, Salomon G. Multiparametric ultrasound: evaluation of greyscale, shear wave elastography and contrast-enhanced ultrasound for prostate cancer detection and localization in correlation to radical prostatectomy specimens. BMC Urol. 2018 Nov 8;18(1):98. doi: 10.1186/s12894-018-0409-5.
- Individual participant dataSharing planned: No. Anonymized data from ultrasound results and histological findings are sent to the TU Eindhoven in Eindhoven (Netherlands) for quantification analysis.
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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.
Georg Salomon, PD Dr. principal investigator
Martini-Klinik am UKE GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Martini-Klinik am UKE GmbH at 1 site in Germany.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 12 Apr 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy in terms of sensitivity and specificity of CEUS, SWE and their combination using radical prostatectomy specimens as the gold-standard. (time frame: 14 days). 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 NCT03091231, which also lists 1 linked publication.
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 12 Apr 2023.