Measurement of Pro-antiangiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)
Recruitment status was Recruiting
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Purpose
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 |
|---|
|
Liver Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Measurement of Pro-antiangiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT) |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Subjects that have undergone Selective Internal Radiation Therapy for the treatment of liver cancer
Inclusion Criteria:
- Patient has 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
Contacts and Locations| Contact: John L. Nosher, MD | 732-235-7721 | nosher@umdnj.edu |
| Contact: Heather McGinn, PA-C | 732-828-3000 ext 4513 | Heather.McGinn@rwjuh.edu |
| United States, New Jersey | |
| Robert Wood Johnson University Hospital | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: John L Nosher, MD 732-235-7721 nosher@umdnj.edu | |
| Contact: Heather McGinn, PA-C 732-828-3000 ext 4513 Heather.McGinn@rwjuh.edu | |
| The Cancer Institute of New Jersey | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Principal Investigator: | John L Nosher, MD | University of Medicine and Dentistry New Jersey |
More Information
No publications provided
| Responsible Party: | Dr. John Nosher, UMDNJ-Robert Wood Johnson Medical School |
| ClinicalTrials.gov Identifier: | NCT00994370 History of Changes |
| Other Study ID Numbers: | 0220080303 |
| Study First Received: | October 13, 2009 |
| Last Updated: | July 20, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
Determine the effect of Selective Internal Radiation Therapy on circulating markers of angiogenesis Develop liver lesion signature patterns using standard imaging studies obtained on patients with hepatic malignancy |
Additional relevant MeSH terms:
|
Liver Neoplasms Neoplasm Metastasis Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Neoplastic Processes Pathologic Processes |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013