Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)
NCT ID: NCT04069468
Last Updated: 2025-07-23
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
1247 participants
OBSERVATIONAL
2019-03-13
2024-12-31
Brief Summary
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Detailed Description
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Clinical data will be collected and held in a secured, validated system and can be downloaded by Biocomplatibles UK Ltd Data Management on an ongoing basis. Data verification will be performed by Biocompatibles UK Ltd Data Management and data validation checks will be created by the validated data system (with the Biocompatibles UK Ltd team performing User Acceptance Testing on them before they go live). Adverse Events and concomitant diseases will be coded according to the version of Medical Dictionary for Regulatory Activities (MedDRA) agreed with Biocompatibles UK Ltd. Concomitant medications will be coded using the version of the World Health Organisation (WHO) Drug dictionary agreed with the validated data system.
Appropriate study plans implemented to manage all aspects of the trial to ensure quality and integrity of the data collection.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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TheraSphere®
Patients with HCC, iCC and mCRC will be treated. TheraSphere is administered in the liver through the hepatic artery. Treatment will be performed according to the Instructions for Use (IFU). Activity of administered TheraSphere is tailored in order to deliver an absorbed dose of 80 to150 gray (Gy) to the liver. Lung dose (D) will be calculated from the following formula: D=A\*(1-S)\*50/1. D=Planned dose absorbed by treated volume(Gy), A=Activity injected with microspheres (gigabequerel \[GBq\]), S=Percentage of pulmonary shunt, "1" assuming that the lung mass=1 kilograms \[kg\]). Number of treatments is up to Investigator's discretion while taking into account the cumulative dose to the liver and lung.
TheraSphere
Participants will receive treatment with TheraSphere in accordance with Instructions for Use
Interventions
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TheraSphere
Participants will receive treatment with TheraSphere in accordance with Instructions for Use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant does not oppose to the collection of his/her medical personal data
Exclusion:
* Participant has opposed to data collection
* Participant has not received a reimbursed dose of TheraSphere® (free of charge dose)
18 Years
ALL
No
Sponsors
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Biocompatibles UK Ltd
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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CHU Amiens
Amiens, , France
CHU, Angers
Angers, , France
CHU Jean Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
Hôpital Haut Leveque
Bordeaux, , France
Centre Hospitalier Régional et Universitaire de Brest
Brest, , France
Hôpital Henri Mondor
Créteil, , France
Centre George-Francois Leclerc
Dijon, , France
CHU Dijon Bourgogne
Dijon, , France
CHU Michallon
Grenoble, , France
Bicêtre Hôpital
Le Kremlin-Bicêtre, , France
CHU Lille
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital de la Croix-Rousse
Lyon, , France
Hopital Edouard Herriot
Lyon, , France
CHU de la Timone
Marseille, , France
Institut Paoli Calmettes
Marseille, , France
CHU Saint Eloi
Montpellier, , France
CHU Brabois Adultes
Nancy, , France
CHU Site Hotel Dieu
Nantes, , France
CHU de l'Archet
Nice, , France
CHU de Nîmes, Hôpital Carremeau
Nîmes, , France
Hopital Beaujon
Paris, , France
Hôpital Cochin, APHP
Paris, , France
Hôpital Saint-Louis
Paris, , France
Centre Hospitalier de Perpignan
Perpignan, , France
Hopital Lyon Sud
Pierre-Bénite, , France
CHU La Milétrie
Poitiers, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
CHU Rouen
Rouen, , France
Centre Hospitalier Universitaire de St Etienne
Saint-Priest-en-Jarez, , France
CHU deHautepierre
Strasbourg, , France
Nouvel Hopital Civil
Strasbourg, , France
CHU Rangueil
Toulouse, , France
Hopital Paul Brousse
Villejuif, , France
Intstitut Gustave Roussy
Villejuif, , France
Countries
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References
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Garin E, Pinaquy JB, Bailly C, Sengel C, Mariano-Goulart D, Edeline J, Blanc JF, Bouvier A, Tordo J, Rode A, Becker S, Sefrioui D, de Baere T, Somma C, Mastier C, Goupil J, Chevallier P, Regnault H, Vibert E, Manfredi S, Vicaut E, Patel B, Boucher E, Guiu B; PROACTIF registry group. Evaluating the Effectiveness of Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Metastatic Colorectal Cancer in Practice: Protocol for the Prospective PROACTIF Phase IV Registry Study in France. Cardiovasc Intervent Radiol. 2022 Jan;45(1):1-11. doi: 10.1007/s00270-021-03002-0. Epub 2021 Nov 18.
Other Identifiers
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BTG-007996-01
Identifier Type: -
Identifier Source: org_study_id
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