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
18 Years
85 Years
Both
Colorectal Cancer, Liver Metastases
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Outcome Measure:
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
Outcome Description:
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.)
Outcome Time Frame:
Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
Safety Issue:
No
Principal Investigator
Jens Ricke, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Magdeburg, Faculty for Medicine
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
RAD050
NCT ID:
NCT01186263
Start Date:
July 2010
Completion Date:
September 2011
Related Keywords:
- Colorectal Cancer
- Liver Metastases
- liver metastases
- MAA
- B20
- SIR spheres
- SPECT
- intra-hepatic distribution
- Colorectal Neoplasms
- Neoplasm Metastasis
- Liver Neoplasms
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