Clinical trial NCT00994370: Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing SIRT
Official title: Measurement of Pro-angiogenic Markers in Patients With Hepatic Metastases Undergoing Selective Internal Radiation Therapy (SIRT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Keywords: Pro-angiogenic markers
SIRT
hepatic metastases
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Sirtex Medical
First posted: 2009-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects that have undergone Selective Internal Radiation Therapy for the treatment of liver cancer

Brief 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.

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 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

Primary outcomes:
measure: Cellular and peptide pro-angiogenic markers in patients with hepatic malignancy before and after SIRT
timeFrame: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment).
Secondary outcomes:
measure: Imaging based predictors
timeFrame: Depending on subject's treatment schedule blood samples are drawn from Day 0 through Day 120 (120 days for whole liver treatment)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: John L Nosher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.2013.10.030. Epub 2013 Dec 20.