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QuiremSpheres Observational Study (Hope166)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563274
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.

Study Description
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Brief Summary:
The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.

Condition or disease Intervention/treatment
Liver, Cancer of, Non-Resectable Device: Selective Internal Radiation Therapy with QuiremSpheres®

Detailed Description:
Liver tumors can be of primary (Hepatocellular Carcinoma, HCC) or metastatic (mainly from colorectal carcinoma, CRC) origin. Both HCC and CRC are common causes of death from cancer worldwide. The overall incidence of HCC and CRC remains high in developing countries and is steadily rising in most industrialized countries. Available treatment options depend on the size, number, and location of tumors, on liver status, overall performance status and comorbidities, on patency of portal vein and presence of extrahepatic metastatic disease. They include surgical (liver resection, liver transplantation), systemic (e.g. chemotherapy, immunotherapy), ablative (thermal ablation, chemical ablation) and intra-arterial (chemoembolization, radioembolization) modalities. Radioembolization, also known as Selective Internal Radiation Therapy (SIRT) with microspheres containing a radiation-emitting isotope (Yttrium-90 or Holmium-166) delivers localized radiation in the vasculature around liver tumors with relatively limited concurrent injury to the surrounding normal/healthy tissue. Yttrium-90 radioembolization is currently included in several guidelines (EASLEORTC, ESMO).
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Observational, Multicenter Study to Further Confirm The Efficacy and Safety of QuiremSpheres® (Holmium-166 Microspheres) Selective Internal Radiation Therapy (SIRT) in Unresectable Liver Cancer Patients.
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Groups and Cohorts
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Intervention Details:
  • Device: Selective Internal Radiation Therapy with QuiremSpheres®
    The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.
    Other Name: SIRT, Radioembolization

Outcome Measures
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Primary Outcome Measures :
  1. Tumor response [ Time Frame: 3 months ]

    1. Tumor response in the liver

    • Tumor response in liver for overall population and each tumor type, assessed 3 months after SIRT has been completed as per routine practice following the corresponding guidelines for each tumor type (e.g. RECIST, mRECIST, EASL)


  2. Safety [ Time Frame: 12 months ]

    2. Frequency and Severity of Adverse Events

    • Safety will be evaluated by monitoring and recording the grade 3, 4 and 5 adverse events (AE) and all adverse device effects (ADE) occurring during and after treatment throughout follow up of patients. Severity of adverse events will be rated following the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Safety assessment will also be based on routine blood tests with an emphasis on the liver function parameters obtained at baseline, after the SIRT procedure and throughout the follow up period.



Secondary Outcome Measures :
  1. Time to progression in liver and overall [ Time Frame: 12 months ]
    Time from SIRT procedure until progression in liver / overall progression

  2. Progression free survival in liver and overall [ Time Frame: 12 months ]
    Time from SIRT procedure until progression in liver / overall progression or death.

  3. Overall survival rate [ Time Frame: 12 months ]
    Time from SIRT procedure until death from any cause

  4. Percentage of patients downstaged to surgery, transplantation or any local ablative therapy (RFA/MWA…) [ Time Frame: 12 months ]
    Number of patients that after the SIRT procedure underwent a surgery or transplantation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with unresectable primary liver cancer or unresectable metastases in the liver.
Criteria

Inclusion Criteria:

  • Patient with diagnosis of primary liver tumor or metastases in the liver from other primary cancers, allocated to SIRT with QuiremSpheres® as decided by a multidisciplinary tumor board
  • Patient is ≥ 18 years
  • Patient has understood and signed written informed consent to data collection in the study

Exclusion Criteria:

  • Patient's refusal
  • Local practice guidelines prohibiting the patient to receive SIRT
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563274


Contacts
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Contact: Dragica Paunovic, MD +32(0)16381311 Dragica.Paunovic@terumo-europe.com
Contact: Florence Chow +32 (0)16 38 13 76 florence.chow@terumo-europe.com

Locations
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Austria
Medizinischen Universität Wien Not yet recruiting
Vienna, Austria, 1090
Contact: Christian Loewe, Prof. Dr.         
Principal Investigator: Christian Loewe, Prof. Dr.         
Belgium
OLV Aalst Not yet recruiting
Aalst, Belgium, 9300
Contact: Pieter De Bondt, Dr.         
Principal Investigator: Pieter De Bondt, Dr.         
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Christophe Deroose, Prof. Dr.         
Principal Investigator: Christophe Deroose, Prof. Dr.         
Germany
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Ralf-Thorsten Hoffmann, MD,PhD         
Principal Investigator: Ralf-Thorsten Hoffmann, MD,PhD         
Italy
Azienda Ospedaliero Universitaria Pisana Not yet recruiting
Pisa, Italy, 56126
Contact: Roberto Cioni, Dr.         
Principal Investigator: Roberto Cioni, Dr.         
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands, 3508 GA
Contact: Marnix Lam, MD,PhD         
Principal Investigator: Marnix Lam, MD,PhD         
Spain
Hospital Universitario Fundación Jiménez Díaz Not yet recruiting
Madrid, Spain, 28015
Contact: Antonio Serrano Palacio, Dr.         
Principal Investigator: Antonio Serrano Palacio, Dr.         
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
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Study Director: Dragica Paunovic, MD Chief Medical Officer at Terumo Europe
More Information
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Additional Information:

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Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT03563274    
Other Study ID Numbers: T131E1
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terumo Europe N.V.:
Hepatocellular Carcinoma,Holmium-166,SIRT,QuiremSpheres®
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases