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Completed

NCT Number: NCT00994370

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Sirtex Medical

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Oct 14, 2009
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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