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

June 26, 2012
July 21, 2014
November 2012
February 2015   (final data collection date for primary outcome 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 [ 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.
Same as current
Complete list of historical versions of study NCT01631318 on ClinicalTrials.gov Archive Site
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3D Dynamic Contrast-Enhanced Ultrasound Imaging in Predicting Treatment Response in Patients With Liver Metastases From Colon Cancer
Pilot Feasibility Study on 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Patients With Liver Metastases

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Liver Metastases
  • Stage IVA Colon Cancer
  • Stage IVB Colon Cancer
  • Colon Cancer
Procedure: dynamic contrast-enhanced ultrasound imaging
Undergo 3D contrast enhanced ultrasound imaging
Other Name: DCE-USI
Experimental: Diagnostic (3D contrast-enhanced ultrasound imaging)
Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks.
Intervention: Procedure: dynamic contrast-enhanced ultrasound imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
10
Not Provided
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01631318
HEP0043, NCI-2012-01008
Not Provided
Stanford University
Stanford University
National Cancer Institute (NCI)
Principal Investigator: Juergen Willmann Stanford University
Stanford University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP