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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02882958

Enrollment

Registered

2016-08-30

Start date

2016-03-31

Completion date

2018-12-31

Last updated

2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Radiology

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results