Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC) (PROACTIF)

Boston Scientific

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Device: TheraSphere

Study type: Observational

Funder types: Industry

Identifiers

NCT04069468

BTG-007996-01

Details and patient eligibility

About

The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in France.

Full description

TheraSphere is a radioembolic therapeutic device used in the treatment of liver cancers. The goal of the registry study is to collect prospectively: participant description, treatment goal, treatment description, treatment results, safety, quality of life and survival data to ultimately demonstrate that TheraSphere treatment meets the claims that led to the reimbursement in France. The registry study is also an opportunity to improve the proper use of the device by team training especially for the personalized dosimetry treatment approach.

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.

Enrollment: 1,247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Participant has received a reimbursed dose of TheraSphere®
• 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)

Trial design

1,247 participants in 1 patient group

TheraSphere®

Description:

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.

Treatment:

Device: TheraSphere