Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing SIRT
|ClinicalTrials.gov Identifier: NCT00994370|
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : March 20, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.
- 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).
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|