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Clinical Trials/EUCTR2008-005609-21-DE
EUCTR2008-005609-21-DE
Active, not recruiting
Not Applicable

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

Faculty For Medicine, Otto-von-Guericke University Magdeburg0 sitesJune 3, 2009
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ConditionsIn 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.MedDRA version: 9.1Level: LLTClassification code 10024700Term: Liver metastases
DrugsTechneScan® LyoMAAROTOP - HSA Mikrosphären B20

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
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.
Sponsor
Faculty For Medicine, Otto-von-Guericke University Magdeburg
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 3, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Faculty For Medicine, Otto-von-Guericke University Magdeburg

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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