Unresectable Hepatocellular CarcinomaNCT03345225
A Clinical Study of Precision TACE (P-TACE) With Surefire
A study testing SureFire Infusion System and Standard Endhole Microcatheter in people with Unresectable Hepatocellular Carcinoma, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- SureFire Infusion System and Standard Endhole Microcatheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2018to Nov 2021
- 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
- Patients > 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy
- Barcelona Clinic Liver Cancer Classification (BCLC) A or B
- Child-Pugh Class A or B
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- 1 to 5 target tumors that are < 6cm with at least one tumor ≥ 3cm in size
- Vessel size ≥ 1.5 mm
- Subject must be able to provide written informed consent
Who cannot join
- Extra-hepatic spread of the cancer
- Macrovascular tumor invasion
- Diffuse HCC (>50% liver involvement)
- Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s)
- Advanced liver disease (bilirubin > 3 mg/dl, aspartate aminotransferase (AST) or ALT > 5x upper limit of normal or > 250 U/I
- Extrahepatic supply to the tumor
Show all 9Show fewer
- Hypovascular tumors
- Heart failure with reduced ejection fraction or Left Ventricular Ejection Fraction (LVEF) ≤ 40 percent
- Any serious medical or psychiatric illness/condition that will interfere or limit compliance with study requirements/treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Study of Precision TACE (P-TACE) With Surefire Infusion Catheter Versus Standard Endhole Catheter (E-TACE) Utilizing Radiopaque Drug Eluting Beads (LUMI) in Patients With Hepatocellular Carcinoma (HCC)
The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- SureFire Infusion System, Standard Endhole Microcatheter
- Keywords
- Chemoembolization (TACE), HCC, Liver Cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SureFire Infusion SystemDevice
Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.
Standard Endhole MicrocatheterDevice
A Microcatheter with a single hole at the end for a infusion.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter Receives: Device: Standard Endhole Microcatheter |
| Surefire Group | Experimental | Participants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System Receives: Device: SureFire Infusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter
The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage.
Measured: 1 month
Secondary outcomes (12)
The Lencioni Score (LS)
The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage.
Measured: 3 months
The Lencioni Score (LS)
The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage.
Measured: 6 months
Objective Response Rate as measured by mRECIST
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Measured: 1 Month
Objective Response Rate as measured by mRECIST
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Measured: 3 Month
Objective Response Rate as measured by mRECIST
Objective Response Rate (ORR) is the proportion of patients who are responders as confirmed with partial response (PR) or confirmed complete response (CR) based on enhancement pattern and size of target lesions
Measured: 6 Month
Distribution of Radiopaque beads
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Measured: 1 Month
Distribution of Radiopaque beads
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Measured: 3 Month
Distribution of Radiopaque beads
Qualitative assessment of the coverage distribution of radiopaque beads, measured on a Likert scale (with response values ranking from 1-5 where 1 is complete coverage and 5 is minimal coverage) in the two treatment arms
Measured: 6 Month
Tumor enhancement
Comparing tumor enhancement relative to a calibrated imaging phantom
Measured: 1 month
Tumor enhancement
Comparing tumor enhancement relative to a calibrated imaging phantom
Measured: 3 month
Tumor enhancement
Comparing tumor enhancement relative to a calibrated imaging phantom
Measured: 6 month
Number of Adverse Event
Adverse Event measured by Common Terminology Criteria for Adverse Event (CTCAE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startMay 2018 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Surefire Medical, Inc.
- Responsible party
- Principal investigator, Shree Venkat, M.D., University of Miami
- Investigators
- Shree Venkat, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345225
- Sponsor's protocol ID
- 20170185
- Status last verified
- Sep 2018
- First submitted
- 13 Nov 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of Precision TACE (P-TACE) With Surefire Infusion Catheter Versus Standard Endhole Catheter (E-TACE) Utilizing Radiopaque Drug Eluting Beads (LUMI) in Patients With Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT03345225
- Acronym / sponsor ID
- 20170185
- Conditions
- Unresectable Hepatocellular Carcinoma
- Keywords
- Chemoembolization (TACE), HCC, Liver Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Surefire Medical, Inc.
- Study start
- May 2018 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 17 Nov 2017 (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.
The purpose of this research study is to learn about 2 types of FDA-approved catheters used in angiographic (X-ray of blood vessels, with radiopaque substance) procedures like DEB-TACE treatment. The Principal Investigator will check the beads given during the DEB-TACE. They will compare the way in which they are spread out in the tumor and density (how condensed something is).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Standard Endhole MicrocatheterParticipants will be randomized to receive DEB-TACE utilizing a standard endhole microcatheter |
| Surefire Group | Experimental | Device: SureFire Infusion SystemParticipants will be randomized to receive DEB-TACE utilizing the Surefire Infusion System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients > 18 years with confirmed diagnosis of unresectable hepatocellular carcinoma who are candidates for TACE therapy
- Barcelona Clinic Liver Cancer Classification (BCLC) A or B
- Child-Pugh Class A or B
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- 1 to 5 target tumors that are < 6cm with at least one tumor ≥ 3cm in size
Key exclusion criteria (9 listed)
- Extra-hepatic spread of the cancer
- Macrovascular tumor invasion
- Diffuse HCC (>50% liver involvement)
- Previous chemotherapy, radiotherapy, transarterial embolization or ablations in the targeted tumor(s)
- Advanced liver disease (bilirubin > 3 mg/dl, aspartate aminotransferase (AST) or ALT > 5x upper limit of normal or > 250 U/I
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 |
|---|---|---|
| SureFire Infusion SystemSurefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream. | Device | Surefire Group |
| Standard Endhole MicrocatheterA Microcatheter with a single hole at the end for a infusion. | Device | Control Group |
Primary outcome
Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter
Time frame: 1 month
The Lencioni score (calculated by comparing pre and post embolization CT attenuation of the tumor averaged over tumor volume) is used to compare the distribution of chemoembolic beads in the tumor to see if the Surefire Infusion system improves tumor coverage.
12 secondary outcomes
The Lencioni Score (LS)
Time frame: 3 months
The Lencioni Score (LS)
Time frame: 6 months
Objective Response Rate as measured by mRECIST
Time frame: 1 Month
Objective Response Rate as measured by mRECIST
Time frame: 3 Month
Objective Response Rate as measured by mRECIST
Time frame: 6 Month
Distribution of Radiopaque beads
Time frame: 1 Month
Distribution of Radiopaque beads
Time frame: 3 Month
Distribution of Radiopaque beads
Time frame: 6 Month
Tumor enhancement
Time frame: 1 month
Tumor enhancement
Time frame: 3 month
Tumor enhancement
Time frame: 6 month
Number of Adverse Event
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Shree Venkat, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SureFire Infusion System and Standard Endhole Microcatheter in people with Unresectable Hepatocellular Carcinoma, run by University of Miami at 1 site in United States.
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 9 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: withdrawn, as of the sponsor's last update on 11 Sep 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Comparing the change in the Lencioni score between the SureFire infusion system and a standard endhole microcatheter (time frame: 1 month). 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 11 Sep 2018.