Clinical validation of a fractional administration device for holmium-166 microspheres during selective internal radiation therapy in patients with liver tumours

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

1. Diagnosis of hepatocellular carcinoma or liver metastases originating from
colorectal cancer
2. At least one lesion of 10 mm in the longest diameter on contrast-enhanced
MRI or contrast-enhanced CT
3. Patient is eligible for SIRT as determined by the tumour board (in Dutch:
MDO)
4. Patient has a life expectancy of 12 weeks or longer
5. Patient has a WHO performance score of 0-2

Exclusion Criteria

1. Significant extrahepatic disease (2x sum of diameters of lesions outside the
liver > sum of lesions inside the liver)
2. Radiation therapy, chemotherapy or major surgery within 4 weeks before
treatment
3. Serum bilirubin > 2.0 x the upper limit of normal
4. ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal
5. Glomerular filtration rate (GFR-MDRD) <35 ml/min
6. Leukocytes <4.0 * 10^9/L or platelet count <60 * 10^9/L
7. Significant heart disease that in the opinion of the physician increases the
risk of ventricular arrhythmia.
8. Pregnancy or breast feeding
9. Disease with increased chance of liver toxicity, such as primary biliary
cirrhosis or xeroderma pigmentosum
10. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants,
etc)
11. Portal vein thrombosis of the main branch (more distal branches are allowed)
12. Evidence of clinically relevant, untreated grade 3 portal hypertension
13. Untreated, active hepatitis
14. Body weight > 150 kg (because of maximum table load)
15. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)
16. Lung shunt > 30 Gy, as calculated using scout dose holmium-166 SPECT/CT
17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in
the falciform ligament, portal lymph nodes or gallbladder are accepted.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine technical performance and accuracy of a novel injection device for<br /><br>SIRT. Additionally, the safety of the device will be assessed. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To perform dosimetry based on MRI and SPECT imaging of holmium-166 and<br /><br>correlate this to tumour response. To investigate the potential added value of<br /><br>gated 166Ho-SPECT/CT compared to conventional 166Ho-SPECT/CT . To investigate<br /><br>the added value of a novel reconstruction algorithm for cone-beam CT (CAVAREC)<br /><br>that compensates for motion during CT acquisition. Local response evaluation at<br /><br>3 months after treatment through contrast-enhanced MRI and/or contrast-enhanced<br /><br>CT, according to mRECIST/RECIST 1.1 criteria (depending on tumour type).</p><br>