NCT05736094

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

February 10, 2023

Last Update Submit

April 3, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

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

    Sensitivity and specificity outcome measures

    1 day

  • 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

Study Arms (1)

Dual-frequency ultrasound

OTHER

Dual-frequency ultrasound for detection of prostate cancer

Device: SURF

Interventions

SURFDEVICE

Dual-frequency ultrasound

Dual-frequency ultrasound

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly men will be included as prostate cancer does not appear in women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years onwards
  • Signed written informed consent to perform rectal and transperineal ultrasound

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0379, Norway

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Wolfgang Lilleby, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2023

First Posted

February 21, 2023

Study Start

February 14, 2023

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations

NO(1)