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

Liver Cancer Clinical Trial

— CONTROL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05183776
• Other study ID #: CONTROL
• Status: Completed
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: August 8, 2023

Study information

• Verified date: October 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Primary Liver Cancer

Intervention

Device:
• Fractional administration device
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.

Locations

Country	Name	City	State
Netherlands	RadboudUMC	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Terumo Medical Corporation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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