Utility of Intra-operative Image Guidance System for Missing Metastases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02806037

Enrollment

Registered

2016-06-20

Start date

2015-11-30

Completion date

2021-02-26

Last updated

2023-06-18

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

Conditions

Colorectal Cancer, Metastatic to the Liver

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results