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Liver MetastasisPhase 1HEPARNCT01031784

Radioactive Holmium Microspheres for the Treatment of Liver Metastases

A Phase 1 study testing holmium-166 poly lactic acid microspheres and holmium 166 microspheres in people with Liver Metastasis and Liver Tumors, 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

The HEPAR study is aimed at determining the safety of radioactive holmium containing microspheres for the treatment of tumors in the liver. These microspheres will be administered by infusion in the liver artery using a arterial catheter in the femoral artery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Metastasis, Liver Tumors
What is being tested?
holmium-166 poly lactic acid microspheres and holmium 166 microspheres
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteNetherlands
Study dates
Dec 2009to Dec 2011
Phase
Phase 1
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

Who may be able to join

  • Patients meeting the following criteria may enter the study:
  • Patients must have given written informed consent.
  • Female or male aged 18 years and over.
  • Confirmed histological diagnosis of metastatic malignancy with dominant liver metastases without standard therapeutic options for treatment including chemotherapy or surgery. Dominant liver metastases are defined (according to the Response Evaluation Criteria in Solid Tumors (RECIST) methodology, see Appendix IV) as the diameter of all metastases in the liver must be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
  • Life expectancy of 12 weeks or longer.
  • World Health Organisation (WHO) Performance status 0-2 (see Appendix III).
  • One or more measurable lesions at least 10 mm in the longest diameter by spiral Computed Tomography (CT) scan (5 mm slice thickness) according to the RECIST criteria.
  • Negative pregnancy test for women of childbearing potential. -

Who cannot join

  • Patients meeting any of the following criteria cannot enter the study:
  • 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 chemotherapy 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 3.0, see Appendix II) grade 2 from previous anti-cancer therapy.
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  • Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
  • Serum creatinine > 185 µmol/L.
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
  • Leukocytes < 4.0 109/l and/or platelet count < 150 109/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).
  • Comorbidity with a grave prognosis (estimated survival <3 months) and/or worse then the basic disease for which the patients will be included in the study.
  • Patients with abnormalities of the bile ducts (such as stents) with a increased chance of infections of the bile ducts.
  • Patients suffering from diseases with a 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 who are declared incompetent.
  • Previous enrolment in the present study or previous treatment with radio-embolisation.
  • Treated with an investigational agent within 42 days prior to starting study treatment.
  • Female patients who are not using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) OR are less than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form) to prevent pregnancy.
  • Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner.
  • Evidence of portal hypertension, splenomegaly or ascites.
  • Body weight over 150 kg.
  • Active hepatitis (B and/or C).
  • Liver weight > 3 kg (determined by software using CT data).
  • Allergy for i.v. contrast used (Visipaque®).
  • MRI contra-indications: severe claustrophobia, metal shrapnel, implanted pacemaker and/or neurostimulators.
  • -

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: Radioactive Holmium Microspheres for the Treatment of Patients With Non-resectable Liver Metastases of Mixed Origin; a Single Center, Interventional, Non-randomized, Open Label, Safety Study.

The HEPAR study is aimed at determining the safety of radioactive holmium containing microspheres for the treatment of tumors in the liver. These microspheres will be administered by infusion in the liver artery using a arterial catheter in the femoral artery.

Being tested
holmium-166 poly lactic acid microspheres, holmium 166 microspheres
Keywords
liver metastasis, Liver tumors, microspheres, holmium, toxicity
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • holmium-166 poly lactic acid microspheresDevice

    Intra arterial administration of radioactive Holmium 166 microspheres; 600 mg with a specific activity ranging from 1260 MBq per kilo liver weight to 5040 MBq in the highest dose

  • holmium 166 microspheresDevice

    intra arterial administration of holmium 166 microsphers in the hepatic artery

Study groups in NCT01031784
Study groupRoleWhat they receive
Holmium-166 microspheres, intra-arterialExperimentalintra-arterial administration of holmium-166 microspheres in the liver
Receives: Device: holmium-166 poly lactic acid microspheres; Device: holmium 166 microspheres

What is being measured

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

  1. Toxicity of Ho-166 poly lactic microspheres using CTC vs 3 criteria

    Measured: 12 weeks

Secondary outcomes (1)

  1. tumor response according to RECIST criteria

    tumor size will be determined using CT scans and MRI

    Measured: 12 weeks

Timeline

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

  1. First posted15 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2011
  4. Study completionDec 2011

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01031784
Sponsor's protocol ID
08-450
Acronym
HEPAR
Status last verified
Jan 2012
First submitted
14 Dec 2009
Last updated
31 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Vente MA, Nijsen JF, de Wit TC, Seppenwoolde JH, Krijger GC, Seevinck PR, Huisman A, Zonnenberg BA, van den Ingh TS, van het Schip AD. Clinical effects of transcatheter hepatic arterial embolization with holmium-166 poly(L-lactic acid) microspheres in healthy pigs. Eur J Nucl Med Mol Imaging. 2008 Jul;35(7):1259-71. doi: 10.1007/s00259-008-0747-8. Epub 2008 Mar 11.

    PubMed 18330569

  • Bult W, Vente MA, Zonnenberg BA, Van Het Schip AD, Nijsen JF. Microsphere radioembolization of liver malignancies: current developments. Q J Nucl Med Mol Imaging. 2009 Jun;53(3):325-35.

    PubMed 19521312

  • 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

  • Smits ML, Nijsen JF, van den Bosch MA, Lam MG, Vente MA, Mali WP, van Het Schip AD, Zonnenberg BA. Holmium-166 radioembolisation in patients with unresectable, chemorefractory liver metastases (HEPAR trial): a phase 1, dose-escalation study. Lancet Oncol. 2012 Oct;13(10):1025-34. doi: 10.1016/S1470-2045(12)70334-0. Epub 2012 Aug 22.

    PubMed 22920685

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing holmium-166 poly lactic acid microspheres and holmium 166 microspheres in people with Liver Metastasis and Liver Tumors, 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?

The sponsor lists 8 inclusion and 28 exclusion criteria. 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 31 Jan 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Toxicity of Ho-166 poly lactic microspheres using CTC vs 3 criteria (time frame: 12 weeks). 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 NCT01031784, which also lists 6 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 31 Jan 2012.

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