Utility of Intra-operative Image Guidance System for Missing Metastases

NCT ID: NCT02806037

Last Updated: 2023-06-18

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

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2021-02-26

Brief Summary

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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

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Conditions

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Colorectal Cancer Metastatic to the Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Kingham, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

References

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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.

Reference Type DERIVED
PMID: 28935452 (View on PubMed)

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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E15-166

Identifier Type: -

Identifier Source: org_study_id

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