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Hepatocellular CarcinomaNCT02446925

Surefire Catheter Versus Standard End-hole Microcatheter: A Pilot Study

A study testing Surefire® Infusion System and Standard End-hole catheter in people with Hepatocellular Carcinoma, run by Wright State University.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The Surefire Infusion System is a novel catheter initially developed to prevent reflux of embolic material into non-target vascular territories. Further research has demonstrated improved penetration and distribution of embolic material into treated arterial territories. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Surefire® Infusion System and Standard End-hole catheter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
No sites listed yet
Study dates
1 May 2015to 19 Dec 2018
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

  • Lobar-only treatments
  • Patients with biopsy or radiographically proven hepatocellular carcinoma who are not candidates for transplant, surgical resection or ablative therapy
  • Patients 18 years of age and older
  • Patients who are able to provide written informed consent

Who cannot join

  • Patients with Barcelona-Clinic Liver Cancer (BCLC) Stage C disease,
  • Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3,
  • Patients who are unable to tolerate Y-90,
  • Patients with arterial anatomy unsuitable to place Surefire catheter,
  • Patients with uncorrectable coagulopathy,
  • Patients with platelets less than 50 (uncorrectable),
Show all 14Show fewer
  • Bilirubin >3 mg/dl,
  • AST or ALT>5x upper limit of normal,
  • Patients who are unable to tolerate angiography,
  • Patients with < 3 months to live,
  • Patients who meet the standard Y-90 exclusion criteria according to package insert
  • Female patients who are pregnant
  • Patients under the age of 18
  • Patients who are unable to provide written informed consent

About this study

Official title: Surefire Catheter Versus Standard End-hole Microcatheter in Yttrium-90 Distribution and Tissue Penetration: A Pilot Study

The Surefire Infusion System is a novel catheter initially developed to prevent reflux of embolic material into non-target vascular territories. Further research has demonstrated improved penetration and distribution of embolic material into treated arterial territories. The purpose of this study is to compare Y-90 glass microsphere distribution and penetration into cancerous tissue within the liver between a standard endhole catheter and the Surefire Infusion System.

Read the detailed description

Yttrium-90 (Y-90) radioembolization is a minimally invasive trans-arterial treatment for primary and secondary hepatic malignancies that relies on tumor hypervascularity for concentration of radioactive microspheres. The Surefire® Infusion System (SIS) (Westminster, CO) was developed to reduce non-target embolization which can result in morbid complications, especially those involving radioembolic or drug eluting microspheres. Prior to its introduction, radioembolization and other trans-arterial therapies have been performed with standard end-hole catheters. In addition to providing protection against non-target embolization, studies have demonstrated improved penetration of embolic material (tantalum microspheres and Tc-99M labeled MAA) with the use of the SIS when compared to conventional end-hole catheters. To date, no study has demonstrated improved distribution and penetration of yttrium-90 glass microspheres with the use of the Surefire catheter versus a standard end-hole catheter. Y-90 distribution can be evaluated with the use of immediate post-delivery PET/CT imaging as it creates its own pair production and can be imaged in the immediate post delivery period. PET/CT will demonstrate distribution and the dose to tumors can be calculated. The investigators propose a pilot study comparing yttrium-90 tumor distribution and concentration in patients with hepatocellular carcinoma (HCC) with the use of the SIS versus a standard end-hole catheter.

Being tested
Surefire® Infusion System, Standard End-hole catheter
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surefire® Infusion SystemDevice

    Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization

  • Standard End-hole catheterDevice

    Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization

Study groups in NCT02446925
Study groupRoleWhat they receive
Surefire® Infusion SystemExperimentalPatients randomized to the Surefire® Infusion System treatment arm will undergo Y-90 glass microsphere embolization with a Surefire catheter.
Receives: Device: Surefire® Infusion System
Standard End-hole catheterActive comparatorPatients randomized to the standard end-hole catheter treatment arm will undergo Y-90 glass microsphere embolization with a standard end-hole catheter.
Receives: Device: Standard End-hole catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Y-90 distribution and concentration as determined by post embolization PET-CT

    Y-90 distribution and concentration within targeted hepatocellular carcinoma as determined by post embolization PET-CT.

    Measured: Up to 12 months

Secondary outcomes (11)

  1. Secondary outcome (length of duration for arteriogram)

    length of duration for arteriogram

    Measured: Up to 12 months

  2. Secondary outcome (fluoro time duration)

    fluoro time duration

    Measured: Up to 12 months

  3. Secondary outcome (number of vessels requiring coiling)

    number of vessels requiring coiling

    Measured: Up to 12 months

  4. Secondary outcome (tumor response by Response Evaluation Criteria in Solid Tumors)

    tumor response by Response Evaluation Criteria in Solid Tumors (m-RECIST criteria)

    Measured: Up to 12 months

  5. Secondary outcome- toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP))

    toxicities (per standard labs: Total bilirubin; Aspartate aminotransferase (AST); Alanine aminotransferase (ALT); Albumin; International Normalized Ratio (INR); Creatinine; Alpha Fetoprotein (AFP))

    Measured: Up to 12 months

  6. Secondary outcome (time to progression of tumor)

    time to progression of tumor

    Measured: Up to 12 months

  7. Secondary outcome (vessel injury)

    vessel injury

    Measured: Up to 12 months

  8. Secondary outcome (MELD)

    Model for End-Stage Liver Disease (MELD)

    Measured: Up to 12 months

  9. Secondary outcome (CPS)

    Childs-Pugh Score (CPS)

    Measured: Up to 12 months

  10. Secondary outcome (non-target embolization)

    non-target embolization

    Measured: Up to 12 months

  11. Secondary outcome (time to death from first treatment)

    time to death from first treatment

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study start1 May 2015
  3. Primary completion19 Dec 2018
  4. Study completion19 Dec 2018

Why it stopped: Insufficient number of subjects meeting inclusion criteria

Resources

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
Device feasibility
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446925
Sponsor's protocol ID
Advarra - 42093
Status last verified
Jul 2022
First submitted
7 May 2015
Last updated
28 Jul 2022
Results posted
No
Data monitoring committee
No

Publications

  • Arepally A, Chomas J, Kraitchman D, Hong K. Quantification and reduction of reflux during embolotherapy using an antireflux catheter and tantalum microspheres: ex vivo analysis. J Vasc Interv Radiol. 2013 Apr;24(4):575-80. doi: 10.1016/j.jvir.2012.12.018. Epub 2013 Feb 23.

    PubMed 23462064

Questions about this trial

What is this clinical trial studying?

A study testing Surefire® Infusion System and Standard End-hole catheter in people with Hepatocellular Carcinoma, run by Wright State University.

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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

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 was stopped early (reason given: Insufficient number of subjects meeting inclusion criteria). Results are not available in the source record.

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?

Y-90 distribution and concentration as determined by post embolization PET-CT (time frame: Up to 12 months). 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 NCT02446925, which also lists 1 linked publication.

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 28 Jul 2022.

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