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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT02882958
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Primary Completion: 2018-08
• Study Completion: 2018-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prostate Volume on Actual MRI	Within one month after the fiducial placement	A post-procedure MRI performed within one month after the fiducial placement.
Prostate Volume on US reconstruction	During the fiducial placement	A US 3-D sweep will be performed during the fiducial placement.
Prostate Volume based on US/EM reconstruction	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.