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

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631318
• Other study ID #: IRB-24334
• Secondary ID: NCI-2012-010081R
• Status: Completed
• Phase: N/A
• Start date: November 1, 2012
• Est. completion date: September 30, 2020

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Liver Metastases
• Neoplasm Metastasis

Intervention

Procedure:
• Dynamic contrast-enhanced ultrasound imaging
Ultrasound imaging procedure

Device:
• Optical Tracking Device
Optical Tracking Device, manufactured by Atracsys LLC, Switzerland.
• Electromagnetic Tracking Device
Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont.

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI), Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline
Primary	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	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.	2 weeks after chemotherapy initiation
Primary	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	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.	2 months post-treatment