Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01631318 |
Recruitment Status :
Suspended
(Scientific)
First Posted : June 29, 2012
Last Update Posted : September 19, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Metastases Colon Cancer | Procedure: dynamic contrast-enhanced ultrasound imaging | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 Start Date : | November 2012 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | September 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Diagnostic (3D contrast-enhanced ultrasound imaging)
Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks.
|
Procedure: dynamic contrast-enhanced ultrasound imaging
Undergo 3D contrast enhanced ultrasound imaging
Other Name: DCE-USI |
- 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 [ Time Frame: Baseline ]Descriptive statistics will be presented for lesion size, by lesion type, and across lesion types. Lesion shape, depth, vascularization, and border definition will also be categorized by dose and lesion type. Based on the unenhanced ultrasound, the target lesion to liver echogenicity will be categorized by lesion type. Based on the Definity®-enhanced ultrasound, the pattern of enhancement of the target lesion will be summarized by lesion type.
- 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 [ Time Frame: 2 weeks after chemotherapy initiation ]Descriptive statistics will be presented for lesion size, by lesion type, and across lesion types. Lesion shape, depth, vascularization, and border definition will also be categorized by dose and lesion type. Based on the unenhanced ultrasound, the target lesion to liver echogenicity will be categorized by lesion type. Based on the Definity®-enhanced ultrasound, the pattern of enhancement of the target lesion will be summarized by lesion type.
- 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 [ Time Frame: 2 months post-treatment ]Descriptive statistics will be presented for lesion size, by lesion type, and across lesion types. Lesion shape, depth, vascularization, and border definition will also be categorized by dose and lesion type. Based on the unenhanced ultrasound, the target lesion to liver echogenicity will be categorized by lesion type. Based on the Definity®-enhanced ultrasound, the pattern of enhancement of the target lesion will be summarized by lesion type.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631318
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 |
Principal Investigator: | Aya Kamaya | Stanford University |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT01631318 |
Other Study ID Numbers: |
HEP0043 NCI-2012-01008 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 1R01CA195443 ( U.S. NIH Grant/Contract ) |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | September 19, 2019 |
Last Verified: | September 2019 |
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |