Real-time MR imaged treatment with holmium microspheres of patients with primary liver cancer; a single center, interventional, non-randomized, feasibility study

Recruiting

• Conditions: Hepatocellular carcinoma; Liver cancer; 10017990; 10019815

• Registration Number: NL-OMON51293
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Diagnosis of hepatocellular carcinoma BCLC stage B or C
2. At least one lesion of 10 mm or more in the longest diameter on
contrast-enhanced MRI/CT
3. Patient is eligible for TARE 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. Extrahepatic disease that cannot be targeted during the TARE session
(enlarged lymph nodes in the liver hilus are allowed)
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 * 109/L or platelet count <60 * 109/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 portal hypertension combined
with grade 3 oesophageal varices
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 166Ho SPECT/CT.
17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in
the falciform ligament, portal lymph nodes or gallbladder are accepted.
18. Unstable final catheter position due to hepatic artery anatomy, which might
lead to dislocation of the catheter during transfer to the MRI.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the safety and feasibility of MRI guided administration of<br /><br>Ho-166-PLLA-MS in patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include response at 3, 6 and 12 months, and overall<br /><br>survival.</p><br>