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

Primary Purpose

Colorectal Neoplasms, Neoplasm Metastasis, Liver Diseases

Status

Unknown status

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Holmium-166-poly (L-lactic acid) microspheres

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Cancer Liver Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Radiology and Nuclear Medicine, University Medical Center UtrechtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surefire Infusion System

Standard End-hole Microcatheter

Arm Description

Hepatic arterial administrations using the Surefire Infusion System

Hepatic arterial administrations using the standard end-hole microcatheter

Outcomes

Primary Outcome Measures

Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT

Secondary Outcome Measures

Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT

Posttreatment tumor response on CT and 18F-FDG-PET

Predictive value of the holmium-166 scout dose

Dose-response relationship between tumor absorbed doses on SPECT/CT and tumor response on CT and 18F-FDG-PET

Infusion efficiency

Defined as the percentage of calculated treatment activity that was administered

Overall survival

Clinical and laboratory toxicity

According to Common Terminology Criteria for Adverse Events version 4.03

Full Information

NCT ID

NCT02208804

First Posted

July 31, 2014

Last Updated

November 7, 2016

Sponsor

UMC Utrecht

1. Study Identification

Unique Protocol Identification Number

NCT02208804

Brief Title

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

Acronym

SIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2014 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UMC Utrecht

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms, Neoplasm Metastasis, Liver Diseases, Digestive System Neoplasms

Keywords

Colorectal Cancer Liver Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surefire Infusion System

Arm Type

Experimental

Arm Description

Hepatic arterial administrations using the Surefire Infusion System

Arm Title

Standard End-hole Microcatheter

Arm Type

Active Comparator

Arm Description

Hepatic arterial administrations using the standard end-hole microcatheter

Intervention Type

Device

Intervention Name(s)

Holmium-166-poly (L-lactic acid) microspheres

Primary Outcome Measure Information:

Title

Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT

Time Frame

5 days after treatment

Secondary Outcome Measure Information:

Title

Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT

Time Frame

5 days after treatment

Title

Posttreatment tumor response on CT and 18F-FDG-PET

Time Frame

3 months after treatment

Title

Predictive value of the holmium-166 scout dose

Time Frame

On the day of treatment

Title

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

Title

Infusion efficiency

Description

Defined as the percentage of calculated treatment activity that was administered

Time Frame

On the day of treatment

Title

Overall survival

Time Frame

From date of treatment until the date of death from any cause, assessed up to 1 year

Title

Clinical and laboratory toxicity

Description

According to Common Terminology Criteria for Adverse Events version 4.03

Time Frame

Up to 3 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maurice AAJ van den Bosch, Prof. dr.

Phone

+ 31 88 7554755

mbosch@umcutrecht.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Andor F van den Hoven, MD

Phone

+ 31 88 7567375

a.f.vandenhoven@umcutrecht.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maurice AAJ van den Bosch, Prof. dr.

Organizational Affiliation

UMCU Utrecht, The Netherlands

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Max A Viergever, Prof. dr. ir.

Organizational Affiliation

UMC Utrecht, The Netherlands

Official's Role

Study Director

Facility Information:

Facility Name

Department of Radiology and Nuclear Medicine, University Medical Center Utrecht

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

33128132

Citation

van Roekel C, van den Hoven AF, Bastiaannet R, Bruijnen RCG, Braat AJAT, de Keizer B, Lam MGEH, Smits MLJ. Use of an anti-reflux catheter to improve tumor targeting for holmium-166 radioembolization-a prospective, within-patient randomized study. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1658-1668. doi: 10.1007/s00259-020-05079-0. Epub 2020 Oct 31.

Results Reference

derived

PubMed Identifier

27782851

Citation

van den Hoven AF, Prince JF, Bruijnen RC, Verkooijen HM, Krijger GC, Lam MG, van den Bosch MA. Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial. Trials. 2016 Oct 25;17(1):520. doi: 10.1186/s13063-016-1643-3.

Results Reference

derived

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

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