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. Me
Conditions
Interventions
Trade Name: TechneScan® LyoMAA
Product Name: TechneScan® LyoMAA
Pharmaceutical Form: Kit for radiopharmaceutical preparation
INN or Proposed INN: Macrosalb
CAS Number: 54277-47-3
Concentration unit: M
Sponsors
Faculty For Medicine, Otto-von-Guericke University Magdeburg
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the predictive value of MAA injected into the common hepatic artery for the distribution of 90Y SIR-Spheres;Secondary Objective: -To assess the predictive value of B20 microspheres injected into the common hepatic artery for the distribution of 90Y SIR-Spheres -To compare the intrahepatic distribution of MAA and B20 microspheres after injection into the common hepatic artery vs. separate injections into the right and left hepatic artery -To assess the change in shunt volume as well as the intrahepatic distribution of MAA and B20 microspheres after therapy with 90Y labeled SIR spheres· -To compare the intrahepatic distribution of MAA and B20 microspheres when injected alone vs. as a mixture with SIR spheres -To assess the differences in the intra-hepatic distribution of MAA and B20 microspheres vs. 90Y SIR spheres injected simultaneously into the right and left hepatic artery;Primary end point(s): Volume of the intra-hepatic SIR spheres accumulation (from the 2nd and 3rd visit) correctly predicted by the diagnostic 99mTc MAA SPECT (1st visit); visual assessment (0-10%, >10-20%, >20-30%, …, >90-100%) | — |
Countries
Germany
Outcome results
None listed