Safety and Efficacy of Ho-166-Radioembolisation by SPECT- and MR-Image guidance optimized substrate application - a comparative Study to Y-90-Radioembolisatio

Phase 4

• Conditions: C18; C50; Malignant neoplasm of colon; Malignant neoplasm of breast

• Registration Number: DRKS00014139
• Lead Sponsor: niversitätsklinikum Magdeburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 11

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

- 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy and safety of radioembolisation with Ho-166-labeled microspheres (QuiremSpheres) in comparison to Y-90-SIR-Spheres<br>

Secondary Outcome Measures

Name	Time	Method
- Prediction of therapeutically accumulation pattern (QuiremSpheres or SIR-Spheres) by accumulation pattern from pre-therapeutic evaluation (e.g. by Tc-99m-MAA)<br>- Dose response relationship<br>- Quality-of-Life<br>- Estimation of dysfunctional liver volume after RE by contrast media enhanced MRI<br>- Use of MRI (T2*) for dosimetry in Ho-166 labeled microspheres (QuiremSpheres)<br>