Utility of Intra-operative Image Guidance System for Missing Metastases

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Metastatic to the Liver

• Study Type: Observational
• Enrollment (Actual): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the Hepatobiliary Clinic at Memorial Sloan-Kettering Cancer Center.

Description

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
localization rate of liver tumor	estimate the localization rate of Pathfinder to within +/-7%.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Peter Kingham, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

General Publications

• Kingham TP, Pak LM, Simpson AL, Leung U, Doussot A, D'Angelica MI, DeMatteo RP, Allen PJ, Jarnagin WR. 3D image guidance assisted identification of colorectal cancer liver metastases not seen on intraoperative ultrasound: results from a prospective trial. HPB (Oxford). 2018 Mar;20(3):260-267. doi: 10.1016/j.hpb.2017.08.035. Epub 2017 Sep 19.

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): February 26, 2021
• Study Completion (Actual): February 26, 2021

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimated): June 20, 2016

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: E15-166