Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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 distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres (SIR- spheres).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Magdeburg
• Collaborator: Sirtex Medical

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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