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

NCT ID: NCT05183776

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2023-08-08

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.

Conditions

Liver Cancer; Liver Metastasis Colon Cancer; Primary Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study patients

study patients will receive holmium radioembolization using a novel administration device.

Group Type: EXPERIMENTAL

Fractional administration device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank Nijsen, PhD.

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

RadboudUMC

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

CONTROL

Identifier Type: -

Identifier Source: org_study_id