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Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing SIRT

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ClinicalTrials.gov Identifier: NCT00994370
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : March 20, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is being done to investigate the influence of giving radiation to the liver on tumors involving the liver. Investigator is specifically looking at this effect on the blood vessels within the tumor. This effect will be measured by studying substances in the blood that the tumors produce and that cause blood vessels to grow. The effects seen on these substances may help design other treatments to improve the results of the radiation used to treat these tumors.

Condition or disease
Liver Cancer

Detailed Description:
Subjects are invited to participate in this study that have undergone a procedure as their standard of care. This procedure is known as Selective Internal Radiation Therapy (SIRT), a procedure designed for the treatment of cancer in the liver. This includes cancer that has started in the liver as well as cancer that has spread to the liver. The purpose of the study is to collect blood samples to assess for "biological markers," or substances within the blood that may promote cancer growth by causing new blood vessels to form. This study will also use a new method of analyzing medical imaging (CT scan, PET scan) to try and better understand how cancer in the liver forms new blood vessels. SIRT is standard therapy and not part of this study. This study involves blood draws only.

Study Design

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)
Study Start Date : April 2009
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
liver cancer
Patients referred for SIRT will be considered for this investigation. These patients will predominantly have stage IV colorectal metastases with liver dominant metastases or hepatocellular carcinoma. A team of oncologists, interventional radiologists, radiation oncologists and oncologic surgeons will determine that the patients are not candidates for surgical resection or ablative therapy. The patients will then be screened to confirm the patient's eligibility to receive standard of care SIRT treatment. SIRT treatment and imaging studies included in this investigation are standard of care for the patients' liver dominant disease.


Outcome Measures

Primary Outcome Measures :
  1. Cellular and peptide pro-angiogenic markers in patients with hepatic malignancy before and after SIRT [ Time Frame: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment). ]
    Primary objective is to develop assays for both cellular and peptide pro-angiogenic markers and determine variability of these makers in patients with hepatic malignancy before and after Selective Internal Radiation Therapy (SIRT).


Secondary Outcome Measures :
  1. Imaging based predictors [ Time Frame: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment) ]
    To begin to develop imaging based predictors of response to SIRT.


Biospecimen Retention:   Samples Without DNA
Whole blood will be obtained at intervals based on standard of care blood draws. Each sample will be analysed for circulating indicators of angiogenesis.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects that have undergone Selective Internal Radiation Therapy for the treatment of liver cancer
Criteria

Inclusion Criteria:

  • Patients between the ages of 18-85 who have been referred for SIRT as standard of care treatment for hepatocellular carcinoma or colorectal metastases to the liver and qualify for treatment with SIRT
  • Life expectancy of at least 3 months

Exclusion Criteria:

- Patients are excluded from participation in this study if they are not undergoing the SIRT procedure

Contacts and Locations

Information from the National Library of Medicine

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): NCT00994370


Locations
United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Sirtex Medical
Investigators
Principal Investigator: John L Nosher, MD Rutgers, The State University of New Jersey
More Information

Publications:
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00994370     History of Changes
Other Study ID Numbers: 0220080303
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

Keywords provided by Rutgers, The State University of New Jersey:
Pro-angiogenic markers
SIRT
hepatic metastases

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