Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing 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 Design:||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)|
- 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). ] [ Designated as safety issue: No ]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).
- 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) ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994370
|United States, New Jersey|
|Robert Wood Johnson University Hospital|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||John L Nosher, MD||Rutgers, The State University of New Jersey|