Exploratory study to assess the predictive value of 99mTc-labeled albumin spheres for the intrahepatic distribution of 90Y SIR Spheres in patients with liver metastases of colorectal tumors. - Explosive

Active, not recruiting

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10024700Term: Liver metastases; In addition to the assessment of shunt volumes, the intrahepatic distribution of MAA may allow for prediction of tumor radiation dose and the radiation dose to normal liver tissue. Even though MAA might be suitable for this purpose, recent results question the value of MAA. Using Bremsstrahlen imaging it was demonstrated that the intrahepatic distribution of SIR spheres and MAA differ considerably. The reason for the different deposition pattern of MAA vs. SIR spheres is currently not clear.

• Registration Number: EUCTR2008-005609-21-DE
• Lead Sponsor: Faculty For Medicine, Otto-von-Guericke University Magdeburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-03
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.age: between 18 and 85 years
2.if female, postmenopausal or surgically sterilized
3.liver metastases of a colorectal tumor in both liver lobes
4.scheduled for therapy with 90Y SIR spheres for clinical reasons
5.life expectancy longer than 6 months
6.willing and able to undergo all study procedures
7.having voluntarily provided written and fully informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.presenting with a contraindication to 90Y SIR spheres therapy
2.variants of the arterial hepatic blood supply which interfere with the objectives of this study (e.g., variants of Michel)
3.women who are pregnant, lactating or who are of childbearing potential
4.patients being clinically unstable
5.uncooperative, in the investigator’s opinion
6.any contraindication to SIRT treatment
7.any concomitant chemotherapy
8.shunt to the lung >10%
9.shunt to any extrahepatic organ (except the lung)
10.having been previously enrolled in this study
11.participating in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified