C18 C50
Conditions
Interventions
Group 1: Patients with hepatic metastases from colorectal carcinoma or mamma carcinoma and indication for Radioembolisation (RE) with Y-90-microspheres (Y-90-SIR-Spheres)
In this arm treatment is per
Sponsors
Universitätsklinikum Magdeburg
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: - Patients with histopathological and cytological validated non-resectable and/or non-ablative intrahepatic mCRC od Mamma-CA with a liver-only or liver-predominant intra-hepatic spread after exhausted treatment compliant with standards, - ECOG performance status of 0 - 1, - Estimated life expectancy of at least 3 months without any active intervention/treatment, ? - Patients have to be eligible for both treatment options (arm A: SIR-Spheres or arm B: QuiremSpheres) according to the clinical assessment of the treating observer/physician (considering labor-chemical evaluation, results from Tc-99m-MAA evaluation plus further results from clinically available imaging e.g. whole-body F-18-FDG PET/CT)
Exclusion criteria
Exclusion criteria: - Liver-lung-shunt > 20 % or lung exposure >= 25 Gy from application of the radioembolisate, - Preceding external radio therapy of the liver, - Presence of a clinically liver insufficiency, - Anormal vessel anatomy from pre-therapeutic angiogram, with possibility of a significant back flow of hepatic arterial blood into stomach, pancreas or bowel (extra-hepatic-abdominal accumulation from Tc-99m-MAA liver perfusion scintigraphy) which was unremedied by a re-evaluation (Dudeck et al 2012 CVIR), - Treatment with Capecitabin during the last two months before therapy or a planned treatment with Capecitabin early after therapy with QuiremSpheres® or SIR-Spheres®, - Conventional chemotherapy within the last two weeks. (CTx associated hepatotoxicity has to be decreased to < CTCAE grad 2), - Kidney insufficiency restricting contrast-media enhanced imaging (e.g. angiography), - Existence of a contraindication for contrast-media enhanced MRI (e.g. incompatible cardiac pacemaker, limiting kidney insufficiency), - Intra-hepatic lesion immeasurable by RECIST criteria, - Non-liver predominant tumor disease, - Suspicion of untreated metastasis/metastases of the CNS from clinically or imaging examinations, - Pregnancy or nursing, - Within 28 days before randomization participation in an active part of another clinical study, potentially affecting any endpoint of the current study, - Verification of a persisting active infection, affecting execution of treatment or outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy and safety of radioembolisation with Ho-166-labeled microspheres (QuiremSpheres) in comparison to Y-90-SIR-Spheres | — |
Secondary
| Measure | Time frame |
|---|---|
| - Prediction of therapeutically accumulation pattern (QuiremSpheres or SIR-Spheres) by accumulation pattern from pre-therapeutic evaluation (e.g. by Tc-99m-MAA) - Dose response relationship - Quality-of-Life - Estimation of dysfunctional liver volume after RE by contrast media enhanced MRI - Use of MRI (T2*) for dosimetry in Ho-166 labeled microspheres (QuiremSpheres) | — |
Countries
Germany
Contacts
Public ContactAnja Zinke
Universitätsklinikum Magdeburg, Klinik für Radiologie und Nuklearmedizin (Studienbüro)
Outcome results
None listed