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Completed

NCT Number: NCT05111795

Holmium-166 Retrospective Collection of Real-World Data

The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASZ Aalst, Aalst, Belgium

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About this study

This study, with an observational retrospective longitudinal design, is intended to collect data from the devices (QuiremScoutTM Holmium-166 Microspheres, QuiremSpheresTM Holmium-166 Microspheres, and where available, Q-SuiteTM) used in a post-market, real-world setting. It is non-comparative due to the retrospective nature of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with diagnosis of primary liver tumor or metastases in the liver.
  • Patients treated with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres from 15 July 2019 to 15 July 2021.
  • Patient is ≥ 18 years.
  • If required by national regulation, patient has understood and signed written informed consent to retrospective data collection.

Exclusion criteria

  • Patients previously included in prospective interventional study with QuiremScoutTM Holmium-166 Microspheres and/or QuiremSpheresTM Holmium-166 Microspheres.

Treatment and study plan

Selective Internal Radiation Therapy with QuiremSpheresTM Holmium-166 Microspheres

Device

SIRT work-up procedure and SIRT procedure

Other names: SIRT, Radioembolization, TARE

Primary outcomes

  1. Frequency and Severity of Adverse Events

    Time frame: 30 months

    The primary safety endpoint is defined in terms of incidence of adverse events CTCAE (Common Terminology Criteria for Adverse Events) grade ≥ 3, or any grade of a predefined list of events stemming from risk management of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres.

  2. Progression Free Survival (PFS)

    Time frame: 30 months

    Time from SIRT procedure until overall progression or death

  3. Hepatic Progression Free Survival (HPFS)

    Time frame: 30 months

    Time from SIRT procedure until progression in the liver or death

  4. Overall survival (OS)

    Time frame: 30 months

    Time from SIRT procedure until death from any cause

  5. Tumor response in the liver

    Time frame: 3 months

    Response as per routine practice following the guidelines for corresponding tumor type

  6. Lung shunt prediction

    Time frame: 1 month

    Lung shunt prediction will be evaluated by comparing the predicted and actual lung shunt, either in terms of percentage or absorbed dose

Secondary outcomes

  1. Administered activity

    Time frame: 1 month

    The technical performance of SIRT in term of administered activity in Becquerel (GBq or MBq) with QuiremSpheresTM Holmium-166 Microspheres.

  2. Liver volume treated

    Time frame: 1 month

    The technical performance of SIRT in term of liver volume treated in mL with QuiremSpheresTM Holmium-166 Microspheres.

  3. SIRT treatment approach

    Time frame: 1 month

    The technical performance of SIRT in term of treatment approach (selective, lobar, bi-lobar, whole liver) with QuiremSpheresTM Holmium-166 Microspheres.

  4. Tumor absorbed dose

    Time frame: 1 month

    The technical performance of SIRT in term of tumor absorbed dose in Gray (Gy) recorded from post-treatment imaging or based on injected activity and target volume with QuiremSpheresTM Holmium-166 Microspheres.

  5. Normal liver absorbed dose

    Time frame: 1 month

    The technical performance of SIRT in term of normal liver absorbed dose in Gray (Gy) recorded from post-treatment imaging or based on injected activity and target volume with QuiremSpheresTM Holmium-166 Microspheres.

  6. The use of Q-SuiteTM in clinical practice

    Time frame: 1 month

    The use of Q-SuiteTM in clinical practice will be recorded based on the software which is mentioned in the description of treatment or the presence of a Q-SuiteTM generated report in the patient's medical file.

  7. Number of patients downstaged to liver resection or liver transplantation

    Time frame: 30 months

    The number of patients downstaged to liver resection or liver transplantation will be reviewed based on the number of patients that underwent liver resection or liver transplantation after the SIRT procedure

Sponsors and collaborators

Lead sponsor

Terumo Europe N.V.

Industry

Registry information

Acronym: RECORD

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2021
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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