NCT02882958

Brief Summary

The investigators hypothesize software-based fusion/navigation will be accurate to within 3 mm of the reference standard of EM fusion. The investigators aim to evaluate the accuracy of prostate US/MRI software-based fusion/navigation technology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

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

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

2.4 years

First QC Date

May 25, 2016

Last Update Submit

January 4, 2023

Conditions

Prostate Cancer

Keywords

Radiology

Outcome Measures

Primary Outcomes (3)

  • Prostate Volume on Actual MRI

    A post-procedure MRI performed within one month after the fiducial placement.

    Within one month after the fiducial placement

  • Prostate Volume on US reconstruction

    A US 3-D sweep will be performed during the fiducial placement.

    During the fiducial placement

  • Prostate Volume based on US/EM reconstruction

    A 3-D US sweep performed during the fiducial placement and a Electromagnetic tracking data will also be acquired at the same time, and then the two series of data will be used for US/EM reconstruction.

    During the fiducial placement

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be single center study. Subjects will be recruited from those referred to interventional radiology for ultrasound-guided prostate fiducial placement, or those planing to undergo ultrasound-guided prostate fiducial placement in radiotherapy clinic.

You may qualify if:

  • scheduled for ultrasound-guided gold seeds prostate fiducial placement prior to radiotherapy

You may not qualify if:

  • eGFR \< 45 mL/min/1.73m2
  • recent (within 4 weeks) kidney or liver transplant
  • contraindication to prostate MRI
  • patient with cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Anthony E. Samir, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Ultrasound, Department of Radiology, Massachusetts General Hospital

Study Record Dates

First Submitted

May 25, 2016

First Posted

August 30, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

January 6, 2023

Record last verified: 2023-01

Locations

US(1)