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Sponsor withdrew funding
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| Name | Class |
|---|---|
| Surefire Medical, Inc. | INDUSTRY |
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The purpose of this study will be to prospectively evaluate the outcomes of patients with hepatocellular carcinoma (HCC) who undergo DEB-TACE (drug-eluting bead trans-arterial chemoembolization) with the Surefire Precision Infusion System for intentional effect of down-staging patients to OLT.
Patients with HCC and who are considered candidates for liver transplantation but outside Milancriteria and meet the eligibility criteria will be enrolled in the prospective single arm study.
Results of the prospective cohort will be compared to matched historical control patients who were previously treated with DEB-TACE, delivered with standard endhole catheters. This includes all patients treated at the University of Colorado since 2009 treated with 100-300 micron beads for whom follow-up is available.
This is a single institution prospective clinical trial with historical matched controls. This protocol standardizes DEB-TACE delivery with the Surefire Precision Infusion System. This protocol does not change patient therapy. All patient safety monitoring, treatment procedures and follow-up procedures will be performed in accordance with standard clinical practice.
Fifty (50) subjects will be enrolled in the prospective arm. Data from one hundred (100) historical randomly sampled control subjects (1:2 ratio) will be selected.
Subjects will be followed at 1 week, 1 month, 3 months, then every 3 months, following the initial DEB-TACE procedure until the subject receives a liver transplant or death. The study will be concluded upon completion of enrollment and follow-up of the 50 patients. It is estimated that the time to complete patient enrollment and follow-up is 24 months. The estimated date for study completion (complete primary analyses) is June 2018. This is based on the average survival vs. time to transplant at this center. If there are individual patients that extend beyond this period the time may be slightly extended.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB-TACE Procedure with Surefire Precision Infusion System | Experimental | The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surefire Precision Infusion System | Device | All patients enrolled in this protocol will receive DEB-TACE, which is the standard of care prescribed by their physician. Standard 5 Fr and 3 Fr catheters will be used to perform diagnostic angiography to map the hepatic vasculature to the tumor. Using standard technique, the target vessel feeding the tumor will be catheterized and DEB-TACE administered using the Surefire Precision catheter. The Doxorubicin dosing used in the DEB-TACE will be based upon tumor volume. DEB-TACE will be administered until the first of the following endpoints are reached: Achievement of target dose with stasis, leeching of contrast through the expandable tip and development of distal intrahepatic collaterals. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Recurrence Rate (LRR) | For the outcome of local recurrence rate (LRR) we will test the null hypothesis of no difference in the proportion of patients with local recurrence by catheter type using a Fisher's exact test. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | For the outcome of tumor response measured as the change in enhancing tumor size (pretreatment - post treatment) we will evaluate changes at 1 month and 6 month separately. | 6 months |
| Time to Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David T Johnson, MD, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DEB-TACE Procedure With Surefire Precision Infusion System | The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2018 |
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Fifty (50) subjects will be enrolled in the prospective arm.
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For the outcome of time to progression, we will quantify the number of weeks from treatment until tumor progression.
| Every 3 months through 24 months |
| Survival Time | For the outcome of survival time, we will quantify the number of weeks from treatment until death. | Every 3 months through 24 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DEB-TACE Procedure With Surefire Precision Infusion System | The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Recurrence Rate (LRR) | For the outcome of local recurrence rate (LRR) we will test the null hypothesis of no difference in the proportion of patients with local recurrence by catheter type using a Fisher's exact test. | Zero participants analyzed as the study was terminated prior to data for outcome measures to be assessed. No data was collected or analyzed for this outcome measure. | Posted | No | 6 months |
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| Secondary | Tumor Response | For the outcome of tumor response measured as the change in enhancing tumor size (pretreatment - post treatment) we will evaluate changes at 1 month and 6 month separately. | Zero participants analyzed as the study was terminated prior to data for outcome measures to be assessed. No data was collected or analyzed for this outcome measure. | Posted | 6 months |
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| Secondary | Time to Progression | For the outcome of time to progression, we will quantify the number of weeks from treatment until tumor progression. | Zero participants analyzed as the study was terminated. No data was collected or analyzed for this outcome measure. | Posted | Every 3 months through 24 months |
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| Secondary | Survival Time | For the outcome of survival time, we will quantify the number of weeks from treatment until death. | Zero participants analyzed as the study was terminated prior to data for outcome measures to be assessed. No data was collected or analyzed for this outcome measure. | Posted | Every 3 months through 24 months |
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6 months from the baseline procedure with the Surefire device
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DEB-TACE Procedure With Surefire Precision Infusion System | The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire. | 0 | 11 | 2 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Hepatobiliary disorders | Non-systematic Assessment |
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| Infection | General disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flow limiting dissection of the anterior right hepatic artery | Hepatobiliary disorders | Non-systematic Assessment |
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| Abdominal pain | General disorders | Non-systematic Assessment |
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| Nausea | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Chest pain during sleep | General disorders | Non-systematic Assessment |
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| Elevated AFP levels | General disorders | Non-systematic Assessment |
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| Occasional hot flashes | General disorders | Non-systematic Assessment |
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| Mild groin paint post re-treatment | General disorders | Non-systematic Assessment |
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| Elevated Hep C Quantitative PCR | General disorders | Non-systematic Assessment |
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| Muscle wasting | General disorders | Non-systematic Assessment |
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| Abdominal distention | General disorders | Non-systematic Assessment |
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| Edema | General disorders | Non-systematic Assessment |
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| Admission for infection | General disorders | Non-systematic Assessment |
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| Increased AFib | General disorders | Non-systematic Assessment |
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| Blood bilirubin increased | General disorders | Non-systematic Assessment |
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| Hypoalbuminemia | General disorders | Non-systematic Assessment |
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| Elevated INR levels | General disorders | Non-systematic Assessment |
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| Headaches | General disorders | Non-systematic Assessment |
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| Fever and chills | General disorders | Non-systematic Assessment |
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| Post embolization sydrome | General disorders | Non-systematic Assessment |
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| Difficulty with pain control | General disorders | Non-systematic Assessment |
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| Elevated AFP levels | General disorders | Non-systematic Assessment |
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| Elevated lactate whole blood venous levels | General disorders | Non-systematic Assessment |
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| Cough and chest tightness | General disorders | Non-systematic Assessment |
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| Platelet count decreased | General disorders | Non-systematic Assessment |
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| Encephalopathy | General disorders | Non-systematic Assessment |
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| Elevated ammonia levels | General disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment |
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| Acute kidney injury | General disorders | Non-systematic Assessment |
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| Hyperkalemia | General disorders | Non-systematic Assessment |
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| Constipation | General disorders | Non-systematic Assessment |
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| Depression | General disorders | Non-systematic Assessment |
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| Ascites | General disorders | Non-systematic Assessment |
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Zero participants were analyzed as the study was terminated early due to change in funding. No statistical analysis was performed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thor Johnson | University of Colorado | 720-848-1765 | thor.johnson@ucdenver.edu |
| Oct 5, 2018 |
| Prot_SAP_000.pdf |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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