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

Stanford University

Status

Completed

Conditions

Colon Cancer

Liver Metastases

Treatments

Drug: Perflutren

Device: Electromagnetic Tracking Device

Procedure: Dynamic contrast-enhanced ultrasound imaging

Device: Optical Tracking Device

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT01631318

NCI-2012-01008 (Registry Identifier)

IRB-24334

1R01CA195443 (U.S. NIH Grant/Contract)

HEP0043

Details and patient eligibility

About

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

Full description

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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