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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882958
• Other study ID #: 2015P001681
• Status: Completed
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Analogic Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate Volume on Actual MRI	A post-procedure MRI performed within one month after the fiducial placement.	Within one month after the fiducial placement
Primary	Prostate Volume on US reconstruction	A US 3-D sweep will be performed during the fiducial placement.	During the fiducial placement
Primary	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