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Real-time Imaging of Holmium Radioembolization: a Feasibility Study (Emeritus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269499
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Quirem Medical B.V.
Information provided by (Responsible Party):
Radboud University

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

Condition or disease Intervention/treatment Phase
Liver Cancer Liver Metastases Device: QuiremSpheres® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, interventional, feasibility
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-time MR Imaged Treatment With Holmium Microspheres of Patients With Primary or Secondary Liver Cancer; a Feasibility Study
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Holmium

Arm Intervention/treatment
Study patients
All patients receive holmium radioembolization as per usual
Device: QuiremSpheres®
Radioembolization with QuiremSpheres® under MR imaging




Primary Outcome Measures :
  1. Feasibility of MR imaged administration of holmium microspheres [ Time Frame: 1 month after inclusion ]
    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.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 3 months after treatment ]
    Patients are followed up to 3 months after treatment, during which all adverse events are recorded.

  2. Tumor/non-tumor ratio on MR based dosimetry [ Time Frame: 1 month after inclusion ]
    MR based dosimetry is performed immediately after treatment, resulting in dose maps. The dose that the tumor received is divided over the dose that the rest of the liver received.

  3. Comparison of dosimetry in Gray between MR based and SPECT based dose maps [ Time Frame: 1 month after inclusion ]
    Voxel-based dosimetry will be performed, leading to dose-volume histograms with a dose value per voxel in Gray. Statistical testing will be done for differences between these data sets, i.e. the two different imaging modalities (MR based and SPECT based). It is expected that dose-volume histograms will be similar between the two modalities.

  4. Tumor response after 3 months based on CT imaging (according to RECIST 1.1 criteria) [ Time Frame: 3 months after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have given written informed consent.
  2. Female or male aged 18 years and over.
  3. 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.
  4. Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies
  5. Life expectancy of 12 weeks or longer.
  6. World Health Organisation (WHO) Performance status 0-1 (see Appendix III).
  7. 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.
  8. Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

  1. 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
  2. Radiation therapy within the last 4 weeks before the start of study therapy.
  3. The last dose of prior systemic therapy has been received less than 4 weeks prior the start of study therapy.
  4. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy.
  5. 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.
  6. Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
  7. Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
  8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
  9. Leukocytes < 4.0 109/l and/or platelet count < 60 109/l.
  10. 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.
  11. Pregnancy or breast feeding (women of child-bearing potential).
  12. Patients suffering from diseases with an increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
  13. Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
  14. Patients ineligible to undergo MR imaging.
  15. Patients who are claustrophobic.
  16. Patient who had prior liver resection and/or coil placement inside the liver, expected to cause imaging artefacts on MRI that will limit MR quantification.
  17. Patients who are declared incompetent.
  18. Previous enrolment in the present study or previous treatment with radioembolisation.
  19. Portal vein thrombosis (tumour and/or bland) of the main branch (diagnosed on contrast enhanced transaxial images). Involvement of the right or left portal vein branches and more distal is accepted.
  20. Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophago-gastro-duodenoscopy). In these cases, therapy with non-selective beta blocker (propranolol) or rubber band ligation should be instituted according to accepted guidelines. In case of small varices, prophylactic propranolol is advised.
  21. Untreated active hepatitis.
  22. Transjugular intrahepatic portosystemic shunt (TIPS).
  23. Body weight over 150 kg (because of maximum table load).
  24. Severe allergy for intravenous contrast agents used

    1. Iomeron®, because of CT evaluation, pre-treatment angiography and treatment angiography.
    2. Dotarem or Primovist, depending on the agent used at the time of treatment
  25. Lung shunt >30 Gy, as calculated using scout dose SPECT/CT.
  26. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269499


Contacts
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Contact: Frank Nijsen, PhD +31640675781 frank.nijsen@radboudumc.nl
Contact: Joey Roosen, MD +31243619097 joey.roosen@radboudumc.nl

Locations
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Netherlands
Radboud University Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6525GA
Contact: Frank Nijsen, PhD    +31640675781    frank.nijsen@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Quirem Medical B.V.
Investigators
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Principal Investigator: Frank Nijsen, PhD Associate professor

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04269499    
Other Study ID Numbers: 18100 Emeritus
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases