Ultrasound for Detection of Prostate Cancer (SURF)
April 3, 2024 updated by: Wolfgang Lilleby, Oslo University Hospital
Dual-frequency Ultrasound for Detection of Prostate Cancer
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Study Overview
Detailed Description
Prospectively recruited patients before prostatectomy and/or definitive radiotherapy will be included in the study. Dual-frequency ultrasound imaging will be compared to standard transrectal ultrasound and MRI. Imaging of primary tumor with dual-frequency ultrasound technology including the use of microbubble contrast-media.
A prostate biopsy and blood sample will be taken from each patient, for histopathology and explorative biomarkers.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway, 0379
- Oslo University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years onwards
- Signed written informed consent to perform rectal and transperineal ultrasound
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Dual-frequency ultrasound
Dual-frequency ultrasound for detection of prostate cancer
|
Dual-frequency ultrasound
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Time Frame: 1 day
|
Sensitivity and specificity outcome measures
|
1 day
|
|
Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.
Time Frame: 1 day
|
Comparing dual-frequency ultrasound, shear waves ultrasound, CEUS to MRI and histopathological findings
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation against documented diagnosis
Time Frame: 1 day
|
Evaluation based on image data from MRI, standard ultrasound and histopathology
|
1 day
|
|
Evaluation of histopathology
Time Frame: 1 day
|
Evaluation of histopathological findings in biopsies guided by dual-frequency ultrasound imaging
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wolfgang Lilleby, MD PhD, Oslo University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
March 31, 2024
Study Registration Dates
First Submitted
February 10, 2023
First Submitted That Met QC Criteria
February 10, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 3, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 248446
- 313778 (Other Grant/Funding Number: The Research Council of Norway)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.