Real-time Imaging of Holmium Radioembolization: a Feasibility Study

NCT04269499 | Completed

• 1 other identifier: 18100 Emeritus
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility study in which patients with liver tumors are treated with holmium radioembolization under real time MR imaging.

Conditions

Liver Cancer; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Feasibility of MR imaged administration of holmium microspheres

  Feasibility is defined as successful treatment under MRI in at least 4 of 6 patients. Unsuccessful treatment is defined as having to abort the procedure for safety reasons, judged by the interventional radiologist, and having to complete the administration of microspheres under X-ray guidance as in normal practice. Possible reasons for this are uncertainty about the location of the catheter, or luxation of the catheter as a result of transport to the MRI scanner.

  1 month after inclusion

Secondary Outcomes (4)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Up to 3 months after treatment

• Tumor/non-tumor ratio on MR based dosimetry

  1 month after inclusion

• Comparison of dosimetry in Gray between MR based and SPECT based dose maps

  1 month after inclusion

• Tumor response after 3 months based on CT imaging (according to RECIST 1.1 criteria)

  3 months after treatment

Study Arms (1)

Study patients

OTHER

All patients receive holmium radioembolization as per usual

Device: QuiremSpheres®

Interventions

QuiremSpheres® DEVICE

Radioembolization with QuiremSpheres® under MR imaging

Study patients

Eligibility Criteria

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

You may qualify if:

• Patients must have given written informed consent.
• Female or male aged 18 years and over.
• Diagnosis of hepatocellular carcinoma or cholangiocarcinoma in the liver or diagnosis of metastatic malignancy to the liver (primary tumours: colorectal cancer, melanoma, breast cancer or neuro-endocrine tumour) with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
• Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies
• Life expectancy of 12 weeks or longer.
• World Health Organisation (WHO) Performance status 0-1 (see Appendix III).
• One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
• Negative pregnancy test for women of childbearing potential.

You may not qualify if:

• Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week
• Radiation therapy within the last 4 weeks before the start of study therapy.
• The last dose of prior systemic therapy has been received less than 4 weeks prior the start of study therapy.
• Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
• Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0, see Appendix II) grade 2 from previous anti-cancer therapy.
• Serum bilirubin \> 1.5 x Upper Limit of Normal (ULN).
• Glomerular filtration rate \<35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \> 5 x ULN.
• Leukocytes \< 4.0 109/l and/or platelet count \< 60 109/l.
• Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
• Pregnancy or breast feeding (women of child-bearing potential).
• Patients suffering from diseases with an increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
• Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
• Patients ineligible to undergo MR imaging.
• Patients who are claustrophobic.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Quirem Medical B.V.: collaborator

Study Sites (1)

Radboud University Medical Centre

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Related Publications (2)

• van den Brekel A, Snoeijink TJ, de Meijer VE, Boswinkel M, de Jong KP, Roosen J, Arranja AG, Futterer JJ, Ruiter SJS, Nijsen JFW. Spatial distribution of fractionally administered holmium microspheres in non-tumorous human liver tissue: how livers survive transarterial radioembolisation. EJNMMI Res. 2025 Apr 28;15(1):49. doi: 10.1186/s13550-025-01240-8.

  PMID: 40289050 DERIVED

• Roosen J, Westlund Gotby LEL, Arntz MJ, Futterer JJ, Janssen MJR, Konijnenberg MW, van Wijk MWM, Overduin CG, Nijsen JFW. Intraprocedural MRI-based dosimetry during transarterial radioembolization of liver tumours with holmium-166 microspheres (EMERITUS-1): a phase I trial towards adaptive, image-controlled treatment delivery. Eur J Nucl Med Mol Imaging. 2022 Nov;49(13):4705-4715. doi: 10.1007/s00259-022-05902-w. Epub 2022 Jul 13.

  PMID: 35829749 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

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

Model Details: Single-arm, interventional, feasibility

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 13, 2020
• Study Start: November 11, 2019
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Locations

NL (1)