Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing SIRT
March 18, 2014 updated by: Rutgers, The State University of New Jersey
Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Robert Wood Johnson University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects that have undergone Selective Internal Radiation Therapy for the treatment of liver cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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).
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Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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To begin to develop imaging based predictors of response to SIRT.
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Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John L Nosher, MD, Rutgers, the State University of New Jersey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
October 13, 2009
First Submitted That Met QC Criteria
October 13, 2009
First Posted (Estimate)
October 14, 2009
Study Record Updates
Last Update Posted (Estimate)
March 20, 2014
Last Update Submitted That Met QC Criteria
March 18, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0220080303
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