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

NCT05183776 | Completed

• 1 other identifier: CONTROL
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Accurate dosimetry based on MRI and SPECT imaging of holmium-166.

  6 months after treatment

Study Arms (1)

Study patients

EXPERIMENTAL

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

Device: Fractional administration device

Interventions

Fractional administration device 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.

Study patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Significant extrahepatic disease (2x sum of diameters of lesions outside the liver \> sum of lesions inside the liver)
• Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment
• Serum bilirubin \> 2.0 x the upper limit of normal
• ALAT, ASAT, alkaline phosphatase (AF) \> 5x the upper limit of normal
• Glomerular filtration rate (GFR-MDRD) \<35 ml/min
• Leukocytes \<4.0 \* 109/L or platelet count \<60 \* 109/L
• Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia.
• Pregnancy or breast feeding
• Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum
• Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc)
• Portal vein thrombosis of the main branch (more distal branches are allowed)
• Evidence of clinically relevant, untreated grade 3 portal hypertension
• Untreated, active hepatitis
• Body weight \> 150 kg (because of maximum table load)
• Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Terumo Medical Corporation: collaborator

Study Sites (1)

RadboudUMC

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Frank Nijsen, PhD.

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: July 12, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)