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Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization (SIM)

This study is currently recruiting participants.
Verified November 2016 by Maurice A.A.J. van den Bosch, UMC Utrecht
Sponsor:
ClinicalTrials.gov Identifier:
NCT02208804
First Posted: August 5, 2014
Last Update Posted: November 9, 2016
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.
Information provided by (Responsible Party):
Maurice A.A.J. van den Bosch, UMC Utrecht
  Purpose
The objective of the SIM trial is to investigate whether using the Surefire Infusion System during holmium-166 radioembolization increases the posttreatment tumor to non-tumor activity concentration ratio, compared with using a standard end-hole microcatheter.

Condition Intervention Phase
Colorectal Neoplasms Neoplasm Metastasis Liver Diseases Digestive System Neoplasms Device: Holmium-166-poly (L-lactic acid) microspheres Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization for the Treatment of Colorectal Liver Metastases (SIM Trial)

Resource links provided by NLM:


Further study details as provided by Maurice A.A.J. van den Bosch, UMC Utrecht:

Primary Outcome Measures:
  • Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT [ Time Frame: 5 days after treatment ]

Secondary Outcome Measures:
  • Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT [ Time Frame: 5 days after treatment ]
  • Posttreatment tumor response on CT and 18F-FDG-PET [ Time Frame: 3 months after treatment ]
  • Predictive value of the holmium-166 scout dose [ Time Frame: On the day of treatment ]
  • Dose-response relationship between tumor absorbed doses on SPECT/CT and tumor response on CT and 18F-FDG-PET [ Time Frame: 3 months after treatment ]
  • Infusion efficiency [ Time Frame: On the day of treatment ]
    Defined as the percentage of calculated treatment activity that was administered

  • Overall survival [ Time Frame: From date of treatment until the date of death from any cause, assessed up to 1 year ]
  • Clinical and laboratory toxicity [ Time Frame: Up to 3 months after treatment ]
    According to Common Terminology Criteria for Adverse Events version 4.03


Estimated Enrollment: 25
Study Start Date: November 2014
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surefire Infusion System
Hepatic arterial administrations using the Surefire Infusion System
Device: Holmium-166-poly (L-lactic acid) microspheres
Active Comparator: Standard End-hole Microcatheter
Hepatic arterial administrations using the standard end-hole microcatheter
Device: Holmium-166-poly (L-lactic acid) microspheres

Detailed Description:

Study design: clinical within-subject randomized controlled trial.

Study population: 25 patients with unresectable, chemorefractory, liver-dominant colorectal liver metastases.

Intervention: scout and therapeutic doses of holmium-166 microspheres will be administered in the left and right hepatic artery during two sequential angiography procedures on the same day. In all subjects, the use of the Surefire Infusion System and the standard end-hole catheter will be randomly allocated to the infusion site (left and right hepatic artery).

Baseline and follow-up investigation: at baseline and during follow-up, patients will undergo physical examination and laboratory investigations for toxicity assessment, and a whole-body 18F-FDG-PET + dual-phase liver CT (at baseline and 3-months follow-up) for tumor response assessment. After the scout procedure and therapeutic procedure, a holmium-166 SPECT/CT will be obtained for the assessment of the microsphere distribution.

Main study parameters/endpoints:

The primary endpoint is the tumor to non-tumor activity concentration ratio on SPECT/CT.

Secondary endpoints include mean absorbed doses of radioactivity in tumorous and healthy liver tissue, tumor response, the predictive value of holmium-166 scout dose and infusion efficiency. These endpoints will be compared between the Surefire Infusion System and standard microcatheter infusions. A dose-response relationship, clinical toxicity and overall survival will be assessed for the entire cohort.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Histopathologically confirmed diagnosis of adenocarcinoma of the colon or rectum
  • Hepatic metastases with measurable morphological appearance (≥ 1 cm) on cross sectional imaging, located in the right and left hepatic arterial perfusion territory
  • Unresectable, liver dominant disease
  • Progressive disease after second line chemotherapy or no further chemotherapeutical treatment options due to severe side effects or unwillingness of the patient to undergo systemic chemotherapy
  • Age ≥ 18 years
  • Expected adequacy of follow-up

Exclusion Criteria:

  • World health organization performance score > 2
  • Inadequate bone marrow function (hemoglobin < 6.0 mmol/l, leukocyte count < 3.0 x 109/l, platelet count < 75x 109/l), inadequate liver function (bilirubin > 35 µmol/l, aspartate aminotransferase / alanine aminotransferase (AST/ALT) > 5 x upper limit of normal (ULN)) or inadequate renal function (creatinine > 1.5 x ULN)
  • Prior hemihepatectomy
  • Compromised biliary system (biliary stent or hepaticojejunostomy)
  • Child Pugh score B7 or worse
  • Active hepatitis B or C
  • Main portal vein thrombosis on CT (or previous portal vein embolization)
  • Severe celiac axis stenosis on CT
  • Unsuitable hepatic arterial anatomy on CT
  • Treatment with systemic chemotherapy within 4 weeks prior to radioembolization
  • Previous participation in a study classified as class III by a radiation safety committee
  • Bleeding diathesis
  • Pregnancy or breast feeding
  • Life expectancy < 3 months
  • Patients who are declared incompetent
  • Any condition that prevents from safe treatment with radioembolization
  Contacts and Locations
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): NCT02208804


Contacts
Contact: Maurice AAJ van den Bosch, Prof. dr. + 31 88 7554755 mbosch@umcutrecht.nl
Contact: Andor F van den Hoven, MD + 31 88 7567375 a.f.vandenhoven@umcutrecht.nl

Locations
Netherlands
Department of Radiology and Nuclear Medicine, University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Maurice AAJ van den Bosch, Prof. dr. UMCU Utrecht, The Netherlands
Study Director: Max A Viergever, Prof. dr. ir. UMC Utrecht, The Netherlands
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maurice A.A.J. van den Bosch, Prof. dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT02208804     History of Changes
Other Study ID Numbers: 14-287/D
First Submitted: July 31, 2014
First Posted: August 5, 2014
Last Update Posted: November 9, 2016
Last Verified: November 2016

Keywords provided by Maurice A.A.J. van den Bosch, UMC Utrecht:
Colorectal Cancer Liver Metastases

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Liver Diseases
Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Intestinal Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases