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NCT05736094 Clinical Trial

Ultrasound for Detection of Prostate Cancer

Prostate Cancer Clinical Trial

— SURF  

Official title:
Dual-frequency Ultrasound for Detection of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05736094
Other study ID # 248446
Secondary ID 313778
Status Completed
Phase N/A
First received
Last updated
Start date February 14, 2023
Est. completion date March 31, 2024

Study information
Verified date April 2024
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date March 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years onwards - Signed written informed consent to perform rectal and transperineal ultrasound Exclusion Criteria: - N/A

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SURF
Dual-frequency ultrasound

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (4)
Lead Sponsor Collaborator
Oslo University Hospital Norwegian University of Science and Technology, The Research Council of Norway, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer. Sensitivity and specificity outcome measures 1 day
Primary Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer. Comparing dual-frequency ultrasound, shear waves ultrasound, CEUS to MRI and histopathological findings 1 day
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