Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT

Study Overview
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Brief Summary
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To investigate the in vivo performance and safety of a novel medical device for the injection of holmium-166 microspheres during radioembolization. The main potential advantage of this device is that it allows for injection of a during treatment determined dose, which is not possible with the current administration tool.

Official Title
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Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours

Conditions
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Liver Cancer, Liver Metastasis Colon Cancer, Primary Liver Cancer

Intervention / Treatment
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* Device: Fractional administration device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of hepatocellular carcinoma or liver metastases originating from colorectal cancer. At least one lesion of ≥10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT Patient is eligible for SIRT as determined by the tumour board (in Dutch: MDO) Patient has a life expectancy of 12 weeks or longer Patient has a WHO performance score of 0-2 Exclusion Criteria: Significant extrahepatic disease (2x sum of diameters of lesions outside the liver > sum of lesions inside the liver) Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment Serum bilirubin > 2.0 x the upper limit of normal ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal Glomerular filtration rate (GFR-MDRD) <35 ml/min Leukocytes <4.0 * 109/L or platelet count <60 * 109/L Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia. Pregnancy or breast feeding Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc) Portal vein thrombosis of the main branch (more distal branches are allowed) Evidence of clinically relevant, untreated grade 3 portal hypertension Untreated, active hepatitis Body weight > 150 kg (because of maximum table load) Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) Lung shunt > 30 Gy, as calculated using scout dose holmium-166 SPECT/CT Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study patients<br>study patients will receive holmium radioembolization using a novel administration device. | Device: Fractional administration device<br>* The novel fractional administration device enable the administration of the microspheres in fractions determined by the user. For this study, 5 fractions of 20% will be administered and validated using MRI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of a fractional administration device for holmium radioembolization | The device will be valid if the administered fractions can be quantified on MRI with a maximal deviation of 15%. | 3 months after treatment | 
| Safety of a fractional administration device for holmium radioembolization | The safety of the device will be determined by monitoring the (S)AE's and (S)ADE's | 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accurate dosimetry based on MRI and SPECT imaging of holmium-166. | To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response | 6 months after treatment |