Liver CancerCONTROLNCT05183776
Clinical Validation of a Fractional Administration Device for Holmium-166 SIRT
A study testing Fractional administration device in people with Liver Cancer and Liver Metastasis Colon Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Metastasis Colon Cancer, Primary Liver Cancer
- What is being tested?
- Fractional administration device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Jul 2022to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours
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.
- Being tested
- Fractional administration device
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional administration deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Study patients | Experimental | study patients will receive holmium radioembolization using a novel administration device. Receives: Device: Fractional administration device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 3 months after treatment
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
Measured: 6 months after treatment
Secondary outcomes (1)
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
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start12 Jul 2022
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Frank Nijsen, PhD., Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183776
- Sponsor's protocol ID
- CONTROL
- Acronym
- CONTROL
- Status last verified
- Oct 2023
- First submitted
- 21 Dec 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Fractional Administration Device for Holmium-166 Microspheres During Selective Internal Radiation Therapy in Patients With Liver Tumours
- ClinicalTrials.gov ID
- NCT05183776
- Acronym / sponsor ID
- CONTROL / CONTROL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Terumo Medical Corporation
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patients | Experimental | Device: Fractional administration devicestudy patients will receive holmium radioembolization using a novel administration device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional administration deviceThe 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. | Device | Study patients |
Primary outcome
Validation of a fractional administration device for holmium radioembolization
Time frame: 3 months after treatment
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
Time frame: 6 months after treatment
The safety of the device will be determined by monitoring the (S)AE's and (S)ADE's
1 secondary outcome
Accurate dosimetry based on MRI and SPECT imaging of holmium-166.
Time frame: 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. Participant data will be available upon reasonable request
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Nijsen, PhD. principal investigator
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional administration device in people with Liver Cancer and Liver Metastasis Colon Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a fractional administration device for holmium radioembolization (time frame: 3 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.