Clinical trial NCT01631318: Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases
Official title: Pilot Technical Feasibility Study on 3D Contrast-enhanced Ultrasound Imaging and to Assess Whether Change in Ultrasound 3D Perfusion Pattern Can Predict Treatment Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Metastases
Colon Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Philips Healthcare
First posted: 2012-06-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Measurements of blood flow, in terms of comparison of the perfusion parameters of the lesion as a predictor of tumor response to treatment and use as a biomarker for response to treatment
timeFrame: Baseline
measure: Measurements of blood flow, in terms of comparison of the perfusion parameters of the lesion as a predictor of tumor response to treatment and use as a biomarker for response to treatment
timeFrame: 2 weeks after chemotherapy initiation
measure: Measurements of blood flow, in terms of comparison of the perfusion parameters of the lesion as a predictor of tumor response to treatment and use as a biomarker for response to treatment
timeFrame: 2 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Aya Kamaya
role: PRINCIPAL_INVESTIGATOR
References: