Prostate CancerAMC_2011_190NCT01481441
Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer
A study testing SonoVue in people with Prostate Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. 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?
- SonoVue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Nov 2015
- 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
- age ≥ 18 years
- signed informed consent
Who cannot join
- Has documented acute prostatitis or urinary tract infections.
- History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts.
- Has had severe cardiac rhythm disorders within the last 7 days.
- Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has received a biopsy procedure within 30 days before admission into this study
- 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
With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva.
The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature.
Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.
- Conditions
- Prostate Cancer
- Being tested
- SonoVue
- Keywords
- Contrast Enhanced Ultrasound (CEUS), Prostate cancer, Quantification, Prostate biopsies, Transrectal ultrasound (TRUS), Microbubbles
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoVueDrug
Also called SonoVue sulphur hexafluoride microbubbles 8 microlitres/ml, Powder and solvent for dispersion for injection., MARKETING AUTHORISATION NUMBER(S): EU/1/01/177/002
2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.
| Study group | Role | What they receive |
|---|---|---|
| SonoVue | Other | Ultrasound Contrast Agent Receives: Drug: SonoVue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification prediction compared with prostate biopsy histology
Prostate cancer detection rate by quantification.
Answering the question: What is the difference in, for malignancy suspicious, areas between CEUS quantification and subjective interpretation in relation to the histological biopsy results?
Measured: 3 years
Secondary outcomes (1)
Quantification prediction compared with prostate biopsy histology
Prostate cancer Gleason score compared to quantification results
Answering the question: Is there a relation between Gleason score and quantification results?
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: New study protocol started including targeted biopsies
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.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- H. Wijkstra, Prof. Dr. Ir., Principal investigator, AMC University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481441
- Sponsor's protocol ID
- NL37231.018.11
- Acronym
- AMC_2011_190
- Status last verified
- Jul 2016
- First submitted
- 21 Nov 2011
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Postema AW, Frinking PJ, Smeenge M, De Reijke TM, De la Rosette JJ, Tranquart F, Wijkstra H. Dynamic contrast-enhanced ultrasound parametric imaging for the detection of prostate cancer. BJU Int. 2016 Apr;117(4):598-603. doi: 10.1111/bju.13116. Epub 2015 Jun 29.
PubMed 25754526
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT01481441
- Acronym / sponsor ID
- AMC_2011_190 / NL37231.018.11
- Conditions
- Prostate Cancer
- Keywords
- Contrast Enhanced Ultrasound (CEUS), Prostate cancer, Quantification, Prostate biopsies, Transrectal ultrasound (TRUS), Microbubbles
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New study protocol started including targeted biopsies
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Nov 2011 (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.
With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva.
The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature.
Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SonoVue | Other | Drug: SonoVueUltrasound Contrast Agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 years
- signed informed consent
Key exclusion criteria (7 listed)
- Has documented acute prostatitis or urinary tract infections.
- History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts.
- Has had severe cardiac rhythm disorders within the last 7 days.
- Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
- Has received a biopsy procedure within 30 days before admission into this study
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 |
|---|---|---|
| SonoVueAlso: SonoVue sulphur hexafluoride microbubbles 8 microlitres/ml, Powder and solvent for dispersion for injection., MARKETING AUTHORISATION NUMBER(S): EU/1/01/177/0022.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary. | Drug | SonoVue |
Primary outcome
Quantification prediction compared with prostate biopsy histology
Time frame: 3 years
Prostate cancer detection rate by quantification. Answering the question: What is the difference in, for malignancy suspicious, areas between CEUS quantification and subjective interpretation in relation to the histological biopsy results?
1 secondary outcome
Quantification prediction compared with prostate biopsy histology
Time frame: 3 years
Results and safety
The study was stopped early (reason given: New study protocol started including targeted biopsies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Results publication: PubMed 25754526Postema AW, Frinking PJ, Smeenge M, De Reijke TM, De la Rosette JJ, Tranquart F, Wijkstra H. Dynamic contrast-enhanced ultrasound parametric imaging for the detection of prostate cancer. BJU Int. 2016 Apr;117(4):598-603. doi: 10.1111/bju.13116. Epub 2015 Jun 29.
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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.
H. Wijkstra, Prof. Dr. Ir. principal investigator
AMC University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SonoVue in people with Prostate Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 7 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: stopped early, as of the sponsor's last update on 6 Jul 2016. 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 Netherlands. 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 was stopped early (reason given: New study protocol started including targeted biopsies). 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?
Quantification prediction compared with prostate biopsy histology (time frame: 3 years). 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 NCT01481441, 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 6 Jul 2016.