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Pilot Feasibility Study on 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Patients With Liver Metastases


N/A
18 Years
N/A
Open (Enrolling)
Both
Liver Metastases, Stage IVA Colon Cancer, Stage IVB Colon Cancer, Colon Cancer

Thank you

Trial Information

Pilot Feasibility Study on 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Patients With 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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

Outcome Description:

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.

Outcome Time Frame:

Baseline

Safety Issue:

No

Principal Investigator

Juergen Willmann

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

HEP0043

NCT ID:

NCT01631318

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Liver Metastases
  • Stage IVA Colon Cancer
  • Stage IVB Colon Cancer
  • Colon Cancer
  • Colonic Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location
Stanford University Stanford, California  94305