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

Not Applicable

Completed

• Conditions: Liver Cancer; Liver Metastasis Colon Cancer; Primary Liver Cancer
• Interventions: Device: Fractional administration device

• Registration Number: NCT05183776
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2022-01-11
• Study Start: 2022-07-12
• Primary Completion: 2023-08-08
• Study Completion: 2023-08-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 * 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 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study patients	Fractional administration device	study patients will receive holmium radioembolization using a novel administration device.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Accurate dosimetry based on MRI and SPECT imaging of holmium-166.	6 months after treatment	To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response

Trial Locations

Locations (1)

RadboudUMC; 🇳🇱 Nijmegen, Netherlands