QuiremSpheres Observational Study (Hope166)
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ClinicalTrials.gov Identifier: NCT03563274 |
Recruitment Status :
Terminated
(did not meet planned recruitment expectations with a slow recruitment rate)
First Posted : June 20, 2018
Last Update Posted : March 29, 2021
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Condition or disease | Intervention/treatment |
---|---|
Liver, Cancer of, Non-Resectable | Device: Selective Internal Radiation Therapy with QuiremSpheres® |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 20 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 : | June 21, 2018 |
Actual Primary Completion Date : | July 31, 2020 |
Actual Study Completion Date : | July 31, 2020 |

- 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
- 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)
- 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.
- Time to progression in liver and overall [ Time Frame: 12 months ]Time from SIRT procedure until progression in liver / overall progression
- Progression free survival in liver and overall [ Time Frame: 12 months ]Time from SIRT procedure until progression in liver / overall progression or death.
- Overall survival rate [ Time Frame: 12 months ]Time from SIRT procedure until death from any cause
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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
Germany | |
Universitätsklinikum Carl Gustav Carus | |
Dresden, Germany, 01307 | |
Netherlands | |
UMC Utrecht | |
Utrecht, Netherlands, 3508 GA |
Study Director: | Dragica Paunovic, MD | Chief Medical Officer at Terumo Europe |
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: | March 29, 2021 |
Last Verified: | March 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatocellular Carcinoma,Holmium-166,SIRT,QuiremSpheres® |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |