Status:
COMPLETED
Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy
Lead Sponsor:
University of Magdeburg
Collaborating Sponsors:
Sirtex Medical
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic artery for the di...
Detailed Description
Patients with metastases of colorectal tumors will be included into this study provided that they are scheduled for 90Y SIR spheres therapy for clinical reasons. Before 90Y SIR spheres therapy, patien...
Eligibility Criteria
Inclusion
- age: between 18 and 85 years
- if female, postmenopausal or surgically sterilized
- liver metastases of a colorectal tumor in both liver lobes
- scheduled for therapy with 90Y SIR spheres for clinical reasons
- life expectancy longer than 6 months
- willing and able to undergo all study procedures
- having voluntarily provided written and fully informed consent
Exclusion
- presenting with a contraindication to 90Y SIR spheres therapy
- variants of the arterial hepatic blood supply which interfere with the objectives of this study (e.g., variants of Michel)
- women who are pregnant, lactating or who are of childbearing potential
- patients being clinically unstable
- uncooperative, in the investigator's opinion
- any contraindication to SIRT treatment
- any concomitant chemotherapy
- shunt to the lung \>10%
- shunt to any extrahepatic organ (except the lung)
- having been previously enrolled in this study
- participating in another prospective clinical trial
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01186263
Start Date
July 1 2010
End Date
August 1 2013
Last Update
September 4 2014
Active Locations (1)
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1
Clinic for Radiology and Nuclear Medicine
Magdeburg, Saxony-Anhalt, Germany, 39120