Measurement of Pro-antiangiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Medicine and Dentistry New Jersey.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sirtex Medical
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00994370
First received: October 13, 2009
Last updated: July 20, 2010
Last verified: July 2010
  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)

Resource links provided by NLM:


Further study details as provided by University of Medicine and Dentistry New Jersey:

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
Study Population

Subjects that have undergone Selective Internal Radiation Therapy for the treatment of liver cancer

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994370

Contacts
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

Locations
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
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Sirtex Medical
Investigators
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