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Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases (HEPAR-2)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01612325
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : August 27, 2015
Information provided by (Responsible Party):
B.A. Zonnenberg, UMC Utrecht

Brief Summary:
Radioembolisation is a known method for the treatment of liver tumors and or livermetastases. Currently small beadlets called microspheres are used that are loaded with the beta radiation emitting Yttrium-90. Holmium-166 microspheres have different physical characteristics including good visualisation in gammacameras due to the gamma emission. Because of the higher specific activity higher radiation doses to the liver will be used compared to the standard Yttrium treatment. It is hypothesized that higher doses of irradiation have an improved antitumor effect.

Condition or disease Intervention/treatment Phase
Liver Neoplasms Device: Holmium-166 polylactic microspheres Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radioactive Holmium Microspheres for the Treatment of Patients With Unresectable Liver Metastases; a Single Center, Interventional, Non-randomized, Phase II (HEPAR II) Trial
Study Start Date : May 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Holmium-166 MS radioembolization
Single radioembolization met Holmium-166 polylactic microspheres administered
Device: Holmium-166 polylactic microspheres
Radioembolisation with 600 mg of Holmium-166 microspheres with a patient liver size adjusted activity. The desired whole liver dose is 60 Gy.

Primary Outcome Measures :
  1. Target lesions tumour response [ Time Frame: 3 month after treatment ]
    After the administration of the Ho-166 microspheres the size of the target lesions in the liver will be determined using RECIST 1.1 criteria using CT scan

Secondary Outcome Measures :
  1. Toxicity according CTC v 4 criteria [ Time Frame: Clinical evaluation after 1,3,6,9,12,24,36,52 weeks ]
    Clinical evaluation and laboratory testing after week 1,3,6,9,12,24,36,52

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

List of inclusion criteria:

  • 1. Patients must have given written informed consent.
  • 2. Female or male aged 18 years and over.
  • 3. Diagnosis of metastatic malignancy to the liver and no detectable malignant disease outside the liver or diagnosis of metastatic malignancy to the liver with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver to 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 for reasons of toxicity
  • 5. Life expectancy of 12 weeks or longer.
  • 6. World Health Organisation (WHO) Performance status 0-2 (see Appendix III).

List of 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 chemotherapy 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 < 150 109/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 a 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 who are declared incompetent.
  15. Previous enrolment in the present study or previous treatment with radioembolisation.

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): NCT01612325

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Department of Radiology University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: Bernard Zonnenberg, MD, PhD UMCU Utrecht Netherlands
Study Director: Martin Hendriks, MD, PhD UMCU Utrecht, Netherlands
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: B.A. Zonnenberg, principal investigator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01612325    
Other Study ID Numbers: UMCU-11-538
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by B.A. Zonnenberg, UMC Utrecht:
liver tumors
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases