Hepatocellular Carcinoma
Conditions
Keywords
Radiofrequency Ablation
Brief summary
This study tests the hypothesis that use of the research RFA (Radiofrequency ablation) Physics Library will result in more frequent technical success (complete necrotization of target tissues) compared to ablations conducted without computer guidance. The RFA Physics Library -- a Planning and Guidance Platform (PGP) (NE Scientific, LLC) -- will be used to support percutaneous liver RFA under CT-guidance by assisting physicians in the identification of ablation targets, assessment of proper ablation probe placement, and projection of the created ablation zones on the CT image.
Detailed description
Patients referred for curative ablation of an HCC by consensus recommendation of the multidisciplinary Liver Tumor Clinic at a 400-bed academic cancer center from June 2018 through December 2021 were considered for participation in the study. Inclusion criteria : patient : over 18 years old , ble to provide informed consent, expected survival \>1 year lesion: HCC, \>2 cm in diameter, located \> 1 cm from any other lesion. procedure : completed using the support of the Accublate simulation software. Software detail at : Hoffer EK, Borsic A, Patel SD. Validation of Software for Patient-Specific Real-Time Simulation of Hepatic Radiofrequency Ablation. Acad Radiol. 2022 Oct;29(10):e219-e227. doi: 10.1016/j.acra.2021.12.018. PMID: 35039220; PMCID: PMC9276838 Treatment: CT-guided RFA with Boston Scientific LeVeen system, RF3000 Generator. . Prophylactic antibiotic General anesthesia; imaging during suspended ventilation, no PEEP Ablation per manufacturer's protocol. Target : tumor + 5 mm margin Planning, targeting, intraprocedural repositioning, assessment of ablation coverage using software simulation in conjunction with manufacturer's data map. Tract ablation Follow-up clinic visit with contrast-enhanced cross-sectional imaging (MRI or CT) at 3 months, then every 3 months x 2 years. Data review for complications, progression of liver disease, evidence of local, regional, or metastatic disease, and additional interventions. Outcome measures: primary : local tumor progression secondary: hepatic tumor progression
Interventions
DEVICERFA Physics Library -- a Planning and Guidance Platform (PGP)
Research software used to support liver RFA of HCC lesions \>2cm
Sponsors
National Cancer Institute (NCI)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age 2. Presence of hepatocellular carcinoma with a size equal or larger than 2cm. 3. Scheduled for CT-guided thermal ablation under General Anesthesia 4. Able to provide written, informed consent
Exclusion criteria
1. Absolute of relative contraindication to MRI: 1. the presence of an electronic implant, such as a pacemaker not approved for MRI 2. the presence of a metal implant, such as an aneurysm clip not approved for MRI 3. claustrophobia 4. the presence of other contraindication(s), such as inability to comfortably lie flat, history of working with metal, other implanted hardware or shrapnel 2. Target tumor adjacent to or within prior ablated or resected site. 3. Serious psychiatric illness not adequately controlled to permit patient cooperation to obtain an MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Technical Success of Tumor Ablation | Success measured at end of RFA procedure, one-time event (lasting up to a few hours) | Technical success is defined as the complete ablation of the target lesion (tumor and 5 mm margin), as determined by operator. |
| Rate of Local Tumor Recurrence | 2 years after RFA treatment | Local recurrence at 2 years is defined as the detection of viable malignant tissues at edge of or within a site which was previously treated by RFA. |
Countries
United States
Participant flow
Recruitment details
patients referred from multidisciplinary Liver Tumor Clinic from 12/2019-12/2021 with a lesion consistent with HCC (AASLD criteria) \> 2 cm diameter, were offered participation in study
Pre-assignment details
Five enrolled were excluded: 4 based on pre-procedure study demonstrating tumor outside criteria (2 \< 2 cm, 2 \> 6 cm diameter); one patient excluded due to technical factors precluding connection of software.
Participants by arm
| Arm | Count |
|---|---|
| Patients patients enrolled and had HCC treated with RFA utilizing Ablation Simulation Guidance software | 57 |
| Patients patients enrolled and had HCC treated with RFA utilizing Ablation Simulation Guidance software | 68 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 20 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Transplanted | 5 |
Baseline characteristics
| Characteristic | Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 34 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 68.2 years STANDARD_DEVIATION 8.94 |
| Alpha Fetoprotein > 20 ng/ml | 8 Participants |
| Biopsy Grade moderately-differentiated | 17 Participants |
| Biopsy Grade not available (LIRADS 5) | 19 Participants |
| Biopsy Grade poorly-differentiated | 5 Participants |
| Biopsy Grade well-differentiated | 16 Participants |
| Child Turcotte Pugh Class A | 32 Participants |
| Child Turcotte Pugh Class B | 18 Participants |
| Child Turcotte Pugh Class C | 7 Participants |
| Cirrhosis Etiology Alcohol | 36 participants |
| Cirrhosis Etiology Hepatitis B | 3 participants |
| Cirrhosis Etiology Hepatitis C | 28 participants |
| Cirrhosis Etiology Metabolic dysfunction-associated steatohepatitis | 19 participants |
| Cirrhosis Etiology other | 2 participants |
| Functional Status (ECOG) 0 | 39 Participants |
| Functional Status (ECOG) 1 | 16 Participants |
| Functional Status (ECOG) 2 | 2 Participants |
| Liver segment location segment II | 3 tumors |
| Liver segment location segment III | 13 tumors |
| Liver segment location segment IV | 7 tumors |
| Liver segment location segment V | 9 tumors |
| Liver segment location segment VI | 8 tumors |
| Liver segment location segment VII | 12 tumors |
| Liver segment location segment VIII | 16 tumors |
| Prior Hepatocellular Carcinoma treatment | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 46 Participants |
| Tumor burden per patient 1 tumor | 43 participants |
| Tumor burden per patient 2 tumors | 8 participants |
| Tumor burden per patient 3 tumors | 4 participants |
| Tumor burden per patient 5 tumors | 2 participants |
| Tumor Size | 2.73 centimeters |
| Within MIlan criteria | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 57 |
| other Total, other adverse events | 4 / 57 |
| serious Total, serious adverse events | 2 / 57 |
Outcome results
Primary
Rate of Local Tumor Recurrence
Local recurrence at 2 years is defined as the detection of viable malignant tissues at edge of or within a site which was previously treated by RFA.
Time frame: 2 years after RFA treatment
Population: KM evaluation for proportion with local recurrence at 2-year follow-up
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Tumors Treated With Ablation Simulation Guidance. | Rate of Local Tumor Recurrence | local recurrence at 2 years | 9 tumors |
| Tumors Treated With Ablation Simulation Guidance. | Rate of Local Tumor Recurrence | no local recurrence at 2 years | 59 tumors |
Primary
Rate of Technical Success of Tumor Ablation
Technical success is defined as the complete ablation of the target lesion (tumor and 5 mm margin), as determined by operator.
Time frame: Success measured at end of RFA procedure, one-time event (lasting up to a few hours)
Population: tumors completely treated (tumor + \>95% of 5 mm margin)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Tumors Treated With Ablation Simulation Guidance. | Rate of Technical Success of Tumor Ablation | complete | 68 tumors |
| Tumors Treated With Ablation Simulation Guidance. | Rate of Technical Success of Tumor Ablation | incomplete | 0 tumors |