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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994370
• Other study ID #: 0220080303
• Status: Completed
• Phase: N/A
• First received: October 13, 2009
• Last updated: March 18, 2014
• Start date: April 2009
• Est. completion date: January 2013

Study information

• Verified date: March 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Sirtex Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carpizo DR, Gensure RH, Yu X, Gendel VM, Greene SJ, Moore DF, Jabbour SK, Nosher JL. Pilot study of angiogenic response to yttrium-90 radioembolization with resin microspheres. J Vasc Interv Radiol. 2014 Feb;25(2):297-306.e1. doi: 10.1016/j.jvir.2013.10.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cellular and peptide pro-angiogenic markers in patients with hepatic malignancy before and after SIRT	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).	Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment).	No
Secondary	Imaging based predictors	To begin to develop imaging based predictors of response to SIRT.	Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment)	No