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

November 7, 2016 updated by: Maurice A.A.J. van den Bosch, UMC Utrecht

Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization for the Treatment of Colorectal Liver Metastases (SIM Trial)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Department of Radiology and Nuclear Medicine, University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT
Time Frame: 5 days after treatment
5 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT
Time Frame: 5 days after treatment
5 days after treatment
Posttreatment tumor response on CT and 18F-FDG-PET
Time Frame: 3 months after treatment
3 months after treatment
Predictive value of the holmium-166 scout dose
Time Frame: On the day of treatment
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
3 months after treatment
Infusion efficiency
Time Frame: On the day of treatment
Defined as the percentage of calculated treatment activity that was administered
On the day of treatment
Overall survival
Time Frame: From date of treatment until the date of death from any cause, assessed up to 1 year
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
Up to 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-287/D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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