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Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT (CONTROL)

Primary Purpose

Liver Cancer, Liver Metastasis Colon Cancer, Primary Liver Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Fractional administration device
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Diagnosis of hepatocellular carcinoma or liver metastases originating from colorectal cancer.
  2. At least one lesion of ≥10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT
  3. Patient is eligible for SIRT as determined by the tumour board (in Dutch: MDO)
  4. Patient has a life expectancy of 12 weeks or longer
  5. Patient has a WHO performance score of 0-2

Exclusion Criteria:

  1. Significant extrahepatic disease (2x sum of diameters of lesions outside the liver > sum of lesions inside the liver)
  2. Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment
  3. Serum bilirubin > 2.0 x the upper limit of normal
  4. ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal
  5. Glomerular filtration rate (GFR-MDRD) <35 ml/min
  6. Leukocytes <4.0 * 109/L or platelet count <60 * 109/L
  7. Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia.
  8. Pregnancy or breast feeding
  9. Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum
  10. Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc)
  11. Portal vein thrombosis of the main branch (more distal branches are allowed)
  12. Evidence of clinically relevant, untreated grade 3 portal hypertension
  13. Untreated, active hepatitis
  14. Body weight > 150 kg (because of maximum table load)
  15. Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist)
  16. Lung shunt > 30 Gy, as calculated using scout dose holmium-166 SPECT/CT
  17. Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.

Sites / Locations

  • RadboudUMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study patients

Arm Description

study patients will receive holmium radioembolization using a novel administration device.

Outcomes

Primary Outcome Measures

Validation of a fractional administration device for holmium radioembolization
The device will be valid if the administered fractions can be quantified on MRI with a maximal deviation of 15%.
Safety of a fractional administration device for holmium radioembolization
The safety of the device will be determined by monitoring the (S)AE's and (S)ADE's

Secondary Outcome Measures

Accurate dosimetry based on MRI and SPECT imaging of holmium-166.
To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response

Full Information

First Posted
December 21, 2021
Last Updated
October 26, 2022
Sponsor
Radboud University Medical Center
Collaborators
Terumo Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05183776
Brief Title
Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT
Acronym
CONTROL
Official Title
Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Terumo Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the in vivo performance and safety of a novel medical device for the injection of holmium-166 microspheres during radioembolization. The main potential advantage of this device is that it allows for injection of a during treatment determined dose, which is not possible with the current administration tool.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Liver Metastasis Colon Cancer, Primary Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study patients
Arm Type
Experimental
Arm Description
study patients will receive holmium radioembolization using a novel administration device.
Intervention Type
Device
Intervention Name(s)
Fractional administration device
Intervention Description
The novel fractional administration device enable the administration of the microspheres in fractions determined by the user. For this study, 5 fractions of 20% will be administered and validated using MRI.
Primary Outcome Measure Information:
Title
Validation of a fractional administration device for holmium radioembolization
Description
The device will be valid if the administered fractions can be quantified on MRI with a maximal deviation of 15%.
Time Frame
3 months after treatment
Title
Safety of a fractional administration device for holmium radioembolization
Description
The safety of the device will be determined by monitoring the (S)AE's and (S)ADE's
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Accurate dosimetry based on MRI and SPECT imaging of holmium-166.
Description
To perform dosimetry based on MRI and SPECT imaging of holmium-166 and correlate this to tumour response
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of hepatocellular carcinoma or liver metastases originating from colorectal cancer. At least one lesion of ≥10 mm in the longest diameter on contrast-enhanced MRI or contrast-enhanced CT Patient is eligible for SIRT as determined by the tumour board (in Dutch: MDO) Patient has a life expectancy of 12 weeks or longer Patient has a WHO performance score of 0-2 Exclusion Criteria: Significant extrahepatic disease (2x sum of diameters of lesions outside the liver > sum of lesions inside the liver) Radiation therapy, chemotherapy or major surgery within 4 weeks before treatment Serum bilirubin > 2.0 x the upper limit of normal ALAT, ASAT, alkaline phosphatase (AF) > 5x the upper limit of normal Glomerular filtration rate (GFR-MDRD) <35 ml/min Leukocytes <4.0 * 109/L or platelet count <60 * 109/L Significant heart disease that in the opinion of the physician increases the risk of ventricular arrhythmia. Pregnancy or breast feeding Disease with increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum Patients ineligible to undergo MR-imaging (claustrophobia, metal implants, etc) Portal vein thrombosis of the main branch (more distal branches are allowed) Evidence of clinically relevant, untreated grade 3 portal hypertension Untreated, active hepatitis Body weight > 150 kg (because of maximum table load) Severe allergy for i.v. contrast (Iomeron, Dotarem and/or Primovist) Lung shunt > 30 Gy, as calculated using scout dose holmium-166 SPECT/CT Uncorrectable extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes or gallbladder are accepted.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Nijsen, PhD.
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
RadboudUMC
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participant data will be available upon reasonable request

Learn more about this trial

Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT

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