Validation of Software-based Fusion of Ultrasound and MRI Images of the Prostate

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Prostate Volume on Actual MRI

Time frame: Within one month after the fiducial placement

A post-procedure MRI performed within one month after the fiducial placement.
Prostate Volume on US reconstruction

Time frame: During the fiducial placement

A US 3-D sweep will be performed during the fiducial placement.
Prostate Volume based on US/EM reconstruction

Time frame: During the fiducial placement

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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

Analogic Corporation

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Aug 30, 2016
Registry last updated: Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed