Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing SIRT

This study has been completed.
Sponsor:
Collaborator:
Sirtex Medical
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00994370
First received: October 13, 2009
Last updated: March 18, 2014
Last verified: March 2014
  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-angiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 36
Study Start Date: April 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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:

  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Sirtex Medical
Investigators
Principal Investigator: John L Nosher, MD Rutgers, The State University of New Jersey
  More Information

Publications:
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00994370     History of Changes
Other Study ID Numbers: 0220080303
Study First Received: October 13, 2009
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Pro-angiogenic markers
SIRT
hepatic metastases

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014