Holmium Radioembolization as Adjuvant Treatment to RFA for Early Stage HCC: Dose Finding Study
NCT ID: NCT03437382
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-07-01
2021-03-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RFA + radioembolization
Quirem Medical Holmium-166 radioembolization microspheres
Quirem Medical Holmium-166 radioembolization microspheres
radioembolisation as adjuvant treatment to RFA
Interventions
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Quirem Medical Holmium-166 radioembolization microspheres
radioembolisation as adjuvant treatment to RFA
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Single HCC lesion with diameter of ≥ 2-5cm or up to three lesions with each lesion measuring no more than 3cm (confined to one lobe)
* HCC diagnosis is based on histology or non-invasive imaging criteria according to EORTC-EASL guidelines
* Child Pugh A or B ≤7
* ECOG performance status ≤ 2
* Bilirubin \< 2mg/dL
* ASAT \< 5x upper limit of normal
* ALAT \< 5x upper limit of normal
* Thrombocytes ≥ 50 X 10\^9/L
Exclusion Criteria
* Tumor location precluding percutaneous RFA
* Bilobar tumor involvement
* Vascular tumor invasion or extrahepatic metastasis
* Hemihepatectomy
* Severe comorbidity (e.g. cardiovascular disease, diabetes with nephropathy, active infections)
* Uncorrectable coagulopathy
* Large arterio-portovenous shunt
* Previous radiotherapy to the liver
* Surgical hepatico-enterostomy
* Hepatic resection with placement of surgical clips that may cause artefacts on MRI
* Incompetent/ mentally disabled
* Pregnancy, inadequate anticonception
* Calculated lung dose \>30Gy
* Creatinine clearance \< 50 ml/min
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Health Holland
OTHER
Quirem Medical B.V.
INDUSTRY
Medtronic
INDUSTRY
Maag Lever Darm Stichting
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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MCBurgmans
Principle Investigator
Locations
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Leiden University Medical Center
Leiden, South Holland, Netherlands
Countries
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References
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Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach S, van Delden OM, Dibbets-Schneider P, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular and Cholangiocarcinoma Group. Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients: a dose-finding study (HORA EST HCC trial). Eur J Nucl Med Mol Imaging. 2024 Jun;51(7):2085-2097. doi: 10.1007/s00259-024-06630-z. Epub 2024 Feb 8.
Hendriks P, Rietbergen DDD, van Erkel AR, Coenraad MJ, Arntz MJ, Bennink RJ, Braat AE, Crobach ASLP, van Delden OM, van der Hulle T, Klumpen HJ, van der Meer RW, Nijsen JFW, van Rijswijk CSP, Roosen J, Ruijter BN, Smit F, Stam MK, Takkenberg RB, Tushuizen ME, van Velden FHP, de Geus-Oei LF, Burgmans MC; Dutch Hepatocellular Cholangiocarcinoma Group. Study Protocol: Adjuvant Holmium-166 Radioembolization After Radiofrequency Ablation in Early-Stage Hepatocellular Carcinoma Patients-A Dose-Finding Study (HORA EST HCC Trial). Cardiovasc Intervent Radiol. 2022 Aug;45(8):1057-1063. doi: 10.1007/s00270-022-03162-7. Epub 2022 May 26.
Other Identifiers
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ZonMW
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
P17.161
Identifier Type: -
Identifier Source: org_study_id
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