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).
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, patients will receive a diagnostic examination with injection of MAA (group A) or B20 (group B) into the common hepatic artery to rule out a relevant shunt volume to the lung or other extra-hepatic locations (e.g., stomach) as recommended by the manufacturer. After the diagnostic scan, therapy with SIR- spheres will be conducted in 2 separate sessions with selective injection of 90Y labeled SIR spheres into the right and left hepatic artery at two separate occasions (routine procedure at the University of Magdeburg, Germany). In addition, therapeutic sessions will include the selective injection of MAA or B20 into the right / left hepatic artery according to a predefined plan (either alone or as a mixture with the SIR spheres).The intra-hepatic distribution of 90Y labeled SIR spheres will be assessed using "Bremsstrahlen"- Single- Photon- Emission- Computed- Tomography (SPECT)- imaging, the distribution of MAA and B20 will be assessed using SPECT imaging.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
24
Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.
Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.
Clinic for Radiology and Nuclear Medicine
Magdeburg, Saxony-Anhalt, Germany
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by Tc-99m MAA will be given by a blinded reader in categories by visual assessment (0-10%, \>10-20%, \>20-30%, …, \>90-100%) (only patients who received Tc-99m MAA during evaluation.)
Time frame: Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy
The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by B20 will be given by a blinded reader in categories by visual assessment (0-10%, \>10-20%, \>20-30%, …, \>90-100%) (only patients who received Tc-99m B20 during evaluation.)
Time frame: Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20.
elimination half-life calculated in \[min\] from the decay-corrected radioactivity concentration measured over the liver; % radioactivity trapped in the liver at the individual measuring time points (of total radioactivity measured over the liver in the first scan); percent lung shunt (percentage of liver activity leaking to the lung at the individual time points)
Time frame: One day prior to SIRT
Adverse events as elicited upon indirect questioning.
Number of patients with adverse events (AEs), number of AEs per patient; descriptive listing of all AEs
Time frame: At any visit.
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