3D Dynamic Contrast-Enhanced Ultrasound Imaging in Predicting Treatment Response in Patients With Liver Metastases From Colon Cancer

This study has suspended participant recruitment.
(Insufficient resources)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01631318
First received: June 26, 2012
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Liver Metastases
Stage IVA Colon Cancer
Stage IVB Colon Cancer
Colon Cancer
Procedure: dynamic contrast-enhanced ultrasound imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Feasibility Study on 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Patients With Liver Metastases

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 colon adenocarcinomas. 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provides written informed consent and is willing to comply with protocol requirements
  • Has colon cancer with liver metastases
  • Has at least 1 metastasis (target lesion) and is scheduled for neo-adjuvant chemotherapy prior to eventual surgery
  • Detected by other imaging modalities (including computed tomography [CT] and magnetic resonance tomography [MRT]) performed for routine staging examination of patients
  • Liver lesions with no previous therapy
  • Must have at least several months life expectancy
  • No Eastern Cooperative Oncology Group (ECOG) or performance status will be employed
  • Has at least 1 colon metastasis:

    • Detected during staging examinations
    • In subjects with known history of colon malignancy
    • Will undergo neo-adjuvant chemotherapy for liver metastases
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Has an acoustic window insufficient for adequate ultrasound examination of the liver
  • Has a metastasis that cannot be identified with unenhanced ultrasound
  • Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of Definity®
  • Has previously been enrolled in and completed this study
  • Is determined by the investigator that the subject is clinically unsuitable for the study
  • Known right to left cardiac shunt, bidirectional or transient
  • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
  • Hypersensitivity to perflutren
  • Has received any chemotherapy to treat liver metastases before admission into this study
  • Is a pregnant or lactating female; exclude the possibility of pregnancy by:

    • Testing on site at the institution serum beta human chorionic gonadotropin (HCG) or urine pregnancy test within 24 hours prior to the start of Definity® administration, surgical history (e.g., tubal ligation or hysterectomy)
    • Post menopausal with a minimum 1 year without menses
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631318

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Juergen Willmann Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01631318     History of Changes
Other Study ID Numbers: HEP0043, NCI-2012-01008
Study First Received: June 26, 2012
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Colonic Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014