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

Colorectal Neoplasms Clinical Trial

— SIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02208804
• Other study ID #: 14-287/D
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 31, 2014
• Last updated: November 7, 2016
• Start date: November 2014

Study information

• Verified date: November 2016
• Source: UMC Utrecht
• Contact: Maurice AAJ van den Bosch, Prof. dr.
• Phone: + 31 88 7554755
• Email: mbosch[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Liver Diseases
• Neoplasm Metastasis
• Neoplasms

Intervention

Device:
• Holmium-166-poly (L-lactic acid) microspheres

Locations

Country	Name	City	State
Netherlands	Department of Radiology and Nuclear Medicine, University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT		5 days after treatment	No
Secondary	Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT		5 days after treatment	No
Secondary	Posttreatment tumor response on CT and 18F-FDG-PET		3 months after treatment	No
Secondary	Predictive value of the holmium-166 scout dose		On the day of treatment	No
Secondary	Dose-response relationship between tumor absorbed doses on SPECT/CT and tumor response on CT and 18F-FDG-PET		3 months after treatment	No
Secondary	Infusion efficiency	Defined as the percentage of calculated treatment activity that was administered	On the day of treatment	No
Secondary	Overall survival		From date of treatment until the date of death from any cause, assessed up to 1 year	No
Secondary	Clinical and laboratory toxicity	According to Common Terminology Criteria for Adverse Events version 4.03	Up to 3 months after treatment	Yes