Real-time Imaging of Holmium Radioembolization: a Feasibility Study

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Feb 12, 2020

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have given written informed consent.
• • 2. Female or male aged 18 years and over.
• • 3. Diagnosis of hepatocellular carcinoma or cholangiocarcinoma in the liver or diagnosis of metastatic malignancy to the liver (primary tumours: colorectal cancer, melanoma, breast cancer or neuro-endocrine tumour) with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
• • 4. Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies
• • 5. Life expectancy of 12 weeks or longer.
• • 6. World Health Organisation (WHO) Performance status 0-1 (see Appendix III).
• • 7. One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
• • 8. Negative pregnancy test for women of childbearing potential.
• Exclusion Criteria:
• • 1. Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week
• • 2. Radiation therapy within the last 4 weeks before the start of study therapy.
• • 3. The last dose of prior systemic therapy has been received less than 4 weeks prior the start of study therapy.
• • 4. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
• • 5. Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0, see Appendix II) grade 2 from previous anti-cancer therapy.
• • 6. Serum bilirubin \> 1.5 x Upper Limit of Normal (ULN).
• • 7. Glomerular filtration rate \<35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
• • 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \> 5 x ULN.
• • 9. Leukocytes \< 4.0 109/l and/or platelet count \< 60 109/l.
• • 10. Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
• • 11. Pregnancy or breast feeding (women of child-bearing potential).
• • 12. Patients suffering from diseases with an increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
• • 13. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
• • 14. Patients ineligible to undergo MR imaging.
• • 15. Patients who are claustrophobic.
• • 16. Patient who had prior liver resection and/or coil placement inside the liver, expected to cause imaging artefacts on MRI that will limit MR quantification.
• • 17. Patients who are declared incompetent.
• • 18. Previous enrolment in the present study or previous treatment with radioembolisation.
• • 19. Portal vein thrombosis (tumour and/or bland) of the main branch (diagnosed on contrast enhanced transaxial images). Involvement of the right or left portal vein branches and more distal is accepted.
• • 20. Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophago-gastro-duodenoscopy). In these cases, therapy with non-selective beta blocker (propranolol) or rubber band ligation should be instituted according to accepted guidelines. In case of small varices, prophylactic propranolol is advised.
• • 21. Untreated active hepatitis.
• • 22. Transjugular intrahepatic portosystemic shunt (TIPS).
• • 23. Body weight over 150 kg (because of maximum table load).
• • 24. Severe allergy for intravenous contrast agents used
• • 1. Iomeron®, because of CT evaluation, pre-treatment angiography and treatment angiography.
• • 2. Dotarem or Primovist, depending on the agent used at the time of treatment
• • 25. Lung shunt \>30 Gy, as calculated using scout dose SPECT/CT.
• • 26. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.