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

Status

Completed

Conditions

Intervention / Treatment

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

  • Norway
      • 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
Device: SURF
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

Oslo University Hospital

Collaborators

University of Oslo
Norwegian University of Science and Technology
The Research Council of Norway

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.

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