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

NCT ID: NCT02882958

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Analogic Corporation

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anthony Samir

Associate Director, Ultrasound, Department of Radiology, Massachusetts General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony E. Samir, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2015P001681

Identifier Type: -

Identifier Source: org_study_id

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