Utility of Intra-operative Image Guidance System for Missing Metastases

Completed

• Conditions: Colorectal Cancer; Metastatic to the Liver

• Registration Number: NCT02806037
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Intraoperatively, the surgeon will interrogate the liver with ultrasound. The time spent by the surgeon using the ultrasound is recorded. If all lesions seen on pre-op imaging were found, the patient does not have the Pathfinder Explorer system applied. If one or more lesions cannot be found, then the Pathfinder Explorer system is calibrated and a tracking device is attached to the ultrasound probe, which the surgeon will use to reattempt localization of the missing tumor. The Pathfinder Explorer system operates in real-time in conjunction with the ultrasound.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-20
• Primary Completion: 2021-02-26
• Study Completion: 2021-02-26
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• patient has one or more colorectal liver metastases, at least one of which is ≤1.5cm in maximal diameter on pre-operative cross sectional imaging
• undergoing liver resection and/or ablation

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
localization rate of liver tumor	1 year	estimate the localization rate of Pathfinder to within +/-7%.