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Liver NeoplasmsPhase 2HEPAR-2NCT01612325

Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases

A Phase 2 study testing Holmium-166 polylactic microspheres in people with Liver Neoplasms, run by UMC Utrecht at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Neoplasms
What is being tested?
Holmium-166 polylactic microspheres
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteNetherlands
Study dates
May 2012to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Department of Radiology University Medical Center Utrecht

    Utrecht, 3584CX

Other trials in Netherlands

About this study

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

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.

Conditions
Liver Neoplasms
Being tested
Holmium-166 polylactic microspheres
Keywords
liver tumors
Medical subject headings
Liver Neoplasms, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Holmium-166 polylactic microspheresDevice

    Radioembolisation with 600 mg of Holmium-166 microspheres with a patient liver size adjusted activity. The desired whole liver dose is 60 Gy.

Study groups in NCT01612325
Study groupRoleWhat they receive
Holmium-166 MS radioembolizationExperimentalSingle radioembolization met Holmium-166 polylactic microspheres administered
Receives: Device: Holmium-166 polylactic microspheres

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target lesions tumour response

    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

    Measured: 3 month after treatment

Secondary outcomes (1)

  1. Toxicity according CTC v 4 criteria

    Clinical evaluation and laboratory testing after week 1,3,6,9,12,24,36,52

    Measured: Clinical evaluation after 1,3,6,9,12,24,36,52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01612325
Sponsor's protocol ID
UMCU-11-538
Acronym
HEPAR-2
Status last verified
Aug 2015
First submitted
1 Jun 2012
Last updated
27 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Smits ML, Nijsen JF, van den Bosch MA, Lam MG, Vente MA, Huijbregts JE, van het Schip AD, Elschot M, Bult W, de Jong HW, Meulenhoff PC, Zonnenberg BA. Holmium-166 radioembolization for the treatment of patients with liver metastases: design of the phase I HEPAR trial. J Exp Clin Cancer Res. 2010 Jun 15;29(1):70. doi: 10.1186/1756-9966-29-70.

    PubMed 20550679

  • Wagemans MEHM, Braat AJAT, van Rooij R, Smits MLJ, Bruijnen RCG, Prince JF, Bol GM, de Jong HWAM, Lam MGEH. Lung Mean Dose Prediction in Transarterial Radioembolization (TARE): Superiority of [166Ho]-Scout Over [99mTc]MAA in a Prospective Cohort Study. Cardiovasc Intervent Radiol. 2024 Apr;47(4):443-450. doi: 10.1007/s00270-023-03656-y. Epub 2024 Feb 7.

    PubMed 38326577

  • Elschot M, Nijsen JF, Lam MG, Smits ML, Prince JF, Viergever MA, van den Bosch MA, Zonnenberg BA, de Jong HW. ((9)(9)m)Tc-MAA overestimates the absorbed dose to the lungs in radioembolization: a quantitative evaluation in patients treated with (1)(6)(6)Ho-microspheres. Eur J Nucl Med Mol Imaging. 2014 Oct;41(10):1965-75. doi: 10.1007/s00259-014-2784-9. Epub 2014 May 13.

    PubMed 24819055

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Holmium-166 polylactic microspheres in people with Liver Neoplasms, run by UMC Utrecht at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesions tumour response (time frame: 3 month after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01612325, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.

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