Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases

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

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-01

Study Completion Date

2020-09-30

Brief Summary

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Patients are invited to participate in a research study of liver perfusion (how blood flows to the liver over time). Researchers hope to learn whether perfusion characteristics of liver metastases may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment. Patients were selected as a possible participant in this study because they are identified as having liver metastases

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Detailed Description

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PRIMARY OBJECTIVES:

I. The purpose of this study is to perform a pilot feasibility study on 3-dimensional (3D) ultrasound imaging of liver metastases and to evaluate whether perfusion characteristics (measurements of blood-flow) of hepatic metastases can predict tumor response to treatment in patients with liver metastases. The investigators long term goal is to assess whether early perfusion changes at 2 weeks after chemotherapy initiation can be used as a non-invasive early biomarker for treatment response assessment.

OUTLINE:

Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy, at 2 weeks, and at 2 months.

Conditions

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Liver Metastases Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (3D contrast-enhanced ultrasound imaging)

Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks.

Group Type EXPERIMENTAL

Dynamic contrast-enhanced ultrasound imaging

Intervention Type PROCEDURE

Ultrasound imaging procedure

Optical Tracking Device

Intervention Type DEVICE

Optical Tracking Device, manufactured by Atracsys LLC, Switzerland.

Electromagnetic Tracking Device

Intervention Type DEVICE

Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont.

Perflutren

Intervention Type DRUG

Perflutren lipid microsphere, IV 0.4 mL. Used as standard contrast agent, not the subject of the study.

Interventions

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Dynamic contrast-enhanced ultrasound imaging

Ultrasound imaging procedure

Intervention Type PROCEDURE

Optical Tracking Device

Optical Tracking Device, manufactured by Atracsys LLC, Switzerland.

Intervention Type DEVICE

Electromagnetic Tracking Device

Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont.

Intervention Type DEVICE

Perflutren

Perflutren lipid microsphere, IV 0.4 mL. Used as standard contrast agent, not the subject of the study.

Intervention Type DRUG

Other Intervention Names

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DCE-USI 3D contrast enhanced ultrasound imaging Definity

Eligibility Criteria

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Inclusion Criteria

* Provides written Informed Consent and is willing to comply with protocol requirements.
* Has at least 1 focal lesion in liver or kidney
* Patient may be (i) in the process of receiving treatment (1 scan session), (ii) never treated (3 scan sessions) or (iii) changing treatment regimen/ type and/or receiving a new form of treatment and/or has been on a treatment break ('holiday')(3 scan session)
* Is at least18 years of age.

Exclusion Criteria

* Is determined by the Investigator that the subject is clinically unsuitable for the study.
* Known right to left cardiac shunt, bidirectional or transient.
* Hypersensitivity to perflutren.
* Hypersenstivity to the contrast agent Definity.
* Pregnant and lactating women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No