Ultrasound for Detection of Prostate Cancer | NCT05736094

Studies
Ultrasound for Detection of Prostate Cancer

NCT05736094

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Apr 5, 2024Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

SURF

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
313778	Other Grant/Funding Number	The Research Council of Norway

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Mar 31, 2024Actual

First Submitted Date

Feb 10, 2023

First Submission Date that Met QC Criteria

Feb 10, 2023

First Posted Date

Feb 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2024

Last Update Posted Date

Apr 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wolfgang Lilleby, Principal Investigator, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Name	Class
Norwegian University of Science and Technology	OTHER
University of Oslo	OTHER
The Research Council of Norway	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dual-frequency ultrasound	Other	Dual-frequency ultrasound for detection of prostate cancer	Device: SURF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SURF	Device	Dual-frequency ultrasound	Dual-frequency ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only men will be included as prostate cancer does not appear in women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolfgang Lilleby, MD PhD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0379	Norway

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided