Colorectal NeoplasmsPhase 2/3SIMNCT02208804
Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization
A Phase 2/3 study testing Holmium-166-poly (L-lactic acid) microspheres in people with Colorectal Neoplasms and Neoplasm Metastasis, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Neoplasm Metastasis, Liver Diseases
- What is being tested?
- Holmium-166-poly (L-lactic acid) microspheres
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Nov 2017
- Phase
- Phase 2/3
- 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
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Department of Radiology and Nuclear Medicine, University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: 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.
Read the 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.
- Being tested
- Holmium-166-poly (L-lactic acid) microspheres
- Keywords
- Colorectal Cancer Liver Metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Liver Diseases, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium-166-poly (L-lactic acid) microspheresDevice
| Study group | Role | What they receive |
|---|---|---|
| Surefire Infusion System | Experimental | Hepatic arterial administrations using the Surefire Infusion System Receives: Device: Holmium-166-poly (L-lactic acid) microspheres |
| Standard End-hole Microcatheter | Active comparator | Hepatic arterial administrations using the standard end-hole microcatheter Receives: Device: Holmium-166-poly (L-lactic acid) microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT
Measured: 5 days after treatment
Secondary outcomes (7)
Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT
Measured: 5 days after treatment
Posttreatment tumor response on CT and 18F-FDG-PET
Measured: 3 months after treatment
Predictive value of the holmium-166 scout dose
Measured: On the day of treatment
Dose-response relationship between tumor absorbed doses on SPECT/CT and tumor response on CT and 18F-FDG-PET
Measured: 3 months after treatment
Infusion efficiency
Defined as the percentage of calculated treatment activity that was administered
Measured: On the day of treatment
Overall survival
Measured: From date of treatment until the date of death from any cause, assessed up to 1 year
Clinical and laboratory toxicity
According to Common Terminology Criteria for Adverse Events version 4.03
Measured: Up to 3 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 posted5 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurice A.A.J. van den Bosch, UMC Utrecht
- Investigators
- Maurice AAJ van den Bosch, Prof. dr., Principal investigator, UMCU Utrecht, The NetherlandsMax A Viergever, Prof. dr. ir., Study director, UMC Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208804
- Sponsor's protocol ID
- 14-287/D
- Acronym
- SIM
- Status last verified
- Nov 2016
- First submitted
- 31 Jul 2014
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33128132van 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.
PubMed 27782851
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surefire Infusion System vs. Standard Microcatheter Use During Holmium-166 Radioembolization for the Treatment of Colorectal Liver Metastases (SIM Trial)
- ClinicalTrials.gov ID
- NCT02208804
- Acronym / sponsor ID
- SIM / 14-287/D
- Keywords
- Colorectal Cancer Liver Metastases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2017 (estimated)
- First posted
- 5 Aug 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surefire Infusion System | Experimental | Device: Holmium-166-poly (L-lactic acid) microspheresHepatic arterial administrations using the Surefire Infusion System |
| Standard End-hole Microcatheter | Active comparator | Device: Holmium-166-poly (L-lactic acid) microspheresHepatic arterial administrations using the standard end-hole microcatheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Holmium-166-poly (L-lactic acid) microspheres | Device | Standard End-hole Microcatheter, Surefire Infusion System |
Primary outcome
Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT
Time frame: 5 days after treatment
7 secondary outcomes
Mean absorbed radiation doses in tumorous and healthy liver tissue on SPECT/CT
Time frame: 5 days after treatment
Posttreatment tumor response on CT and 18F-FDG-PET
Time frame: 3 months after treatment
Predictive value of the holmium-166 scout dose
Time frame: 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
Infusion efficiency
Time frame: 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
Clinical and laboratory toxicity
Time frame: Up to 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Derived from this study: PubMed 33128132van 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.
- Derived from this study: PubMed 27782851van 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.
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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.
Maurice AAJ van den Bosch, Prof. dr. principal investigator
UMCU Utrecht, The Netherlands
Max A Viergever, Prof. dr. ir. study director
UMC Utrecht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Holmium-166-poly (L-lactic acid) microspheres in people with Colorectal Neoplasms and Neoplasm Metastasis, run by UMC Utrecht 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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 Nov 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurice AAJ van den Bosch, Prof. dr. (+ 31 88 7554755, mbosch@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttreatment tumor to non-tumor activity concentration ratio on SPECT/CT (time frame: 5 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02208804, which also lists 2 linked publications.
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 9 Nov 2016.