Utility of Intra-operative Image Guidance System for Missing Metastases
June 15, 2023 updated by: Memorial Sloan Kettering Cancer Center
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
Study Type
Observational
Enrollment (Actual)
25
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
localization rate of liver tumor
Time Frame: 1 year
|
estimate the localization rate of Pathfinder to within +/-7%.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Peter Kingham, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- E15-166
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.