MRI-guided Holmium-166 Radioembolization

NCT05609448 | Unknown DMC

• 1 other identifier: EMERITUS-2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the safety and feasibility of a personalized Ho-166-PLLA-MS TARE approach by using MRI guidance in inoperable patients with HCC.

Conditions

Primary Liver Cancer; Non-Resectable Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; radioembolization; TARE

Outcome Measures

Primary Outcomes (4)

• Toxicity profile of dose administration cohorts

  Determine a safe maximal healthy liver dose for personalised administration of microspheres based on (S)AEs related to liver toxicity due to radioembolisation.

  12 months after treatment

• Safety of MRI-guided radioembolization procedure

  Monitoring (S)AE's related to the investigated combination of MRI-guided 166Ho radioembolization.

  12 months after treatment

• Time constraints of performing intraprocedural MRI-based dosimetry

  Time constraints for image processing in between administration of microspheres, in order to be able to perform the procedure within half a day.

  during treatment procedure

• Feasibility of performing intraprocedural treatment planning

  The ability of deciding on catheter positions and dose aministration during the procedure based on MRI dosimetry by comparing the standard of care treatment plan to the treatment performed during the study.

  during treatment procedure

Secondary Outcomes (1)

• Dosimetry optimization

  12 months after treatment

Study Arms (1)

MRI-guided radioembolization

EXPERIMENTAL

Study patients will receive radioembolization with holmium microspheres in an MRI guided setting.

Procedure: MRI-guided radioembolization

Interventions

MRI-guided radioembolization PROCEDURE

Catheter placement will be performed using fluoroscopy, after which patients are transferred to the MRI scanner, where holmium microspheres are administered based on MRI dosimetry. Thereby, patients get a personalized dose administration.

MRI-guided radioembolization

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 BCLC stage B or C
• At least one lesion of 10 mm or more in the longest diameter on contrast-enhanced MRI/CT
• Patient is eligible for TARE 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:

• Extrahepatic disease that cannot be targeted during the TARE session (enlarged lymph nodes in the liver hilus are allowed)
• 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
• 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)
• Untreated, active hepatitis
• Body weight \> 150 kg (because of maximum table load)
• Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)
• Lung shunt \> 30 Gy, as calculated using scout dose 166Ho SPECT/CT.
• Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.

Sponsors & Collaborators

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

Study Sites (1)

RadboudUMC

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Frank Nijsen, PhD

  Radboud University Medical Center

  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: October 26, 2022
• First Posted: November 8, 2022
• Study Start: May 23, 2023
• Primary Completion: January 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)