Trial Outcomes & Findings for An Intraoperative Guidance Platform for Radio Frequency Ablation (NCT NCT04152343)
NCT ID: NCT04152343
Last Updated: 2024-05-21
Results Overview
Technical success is defined as the complete ablation of the target lesion (tumor and 5 mm margin), as determined by operator.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Success measured at end of RFA procedure, one-time event (lasting up to a few hours)
Results posted on
2024-05-21
Participant Flow
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
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.
Unit of analysis: tumors
Participant milestones
| Measure |
RFA Physics Library- Ablation Simulation Guidance
The RFA Physics Library -- a Planning and Guidance Platform: Research software will be used during percutaneous liver RFA of HCC lesions \>2cm
|
|---|---|
|
Overall Study
STARTED
|
57 68
|
|
Overall Study
Completed Procedure
|
57 68
|
|
Overall Study
Completed 2-3 m Imaging for Efficacy
|
57 68
|
|
Overall Study
COMPLETED
|
29 37
|
|
Overall Study
NOT COMPLETED
|
28 31
|
Reasons for withdrawal
| Measure |
RFA Physics Library- Ablation Simulation Guidance
The RFA Physics Library -- a Planning and Guidance Platform: Research software will be used during percutaneous liver RFA of HCC lesions \>2cm
|
|---|---|
|
Overall Study
Transplanted
|
5
|
|
Overall Study
Death
|
20
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
An Intraoperative Guidance Platform for Radio Frequency Ablation
Baseline characteristics by cohort
| Measure |
Patients
n=68 tumors
patients enrolled and had HCC treated with RFA utilizing Ablation Simulation Guidance software
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
|
Cirrhosis Etiology
Hepatitis C
|
28 participants
n=5 Participants
|
|
Cirrhosis Etiology
Hepatitis B
|
3 participants
n=5 Participants
|
|
Cirrhosis Etiology
Alcohol
|
36 participants
n=5 Participants
|
|
Cirrhosis Etiology
Metabolic dysfunction-associated steatohepatitis
|
19 participants
n=5 Participants
|
|
Cirrhosis Etiology
other
|
2 participants
n=5 Participants
|
|
Child Turcotte Pugh Class
A
|
32 Participants
n=5 Participants
|
|
Child Turcotte Pugh Class
B
|
18 Participants
n=5 Participants
|
|
Child Turcotte Pugh Class
C
|
7 Participants
n=5 Participants
|
|
Functional Status (ECOG)
0
|
39 Participants
n=5 Participants
|
|
Functional Status (ECOG)
1
|
16 Participants
n=5 Participants
|
|
Functional Status (ECOG)
2
|
2 Participants
n=5 Participants
|
|
Tumor burden per patient
1 tumor
|
43 participants
n=5 Participants
|
|
Tumor burden per patient
2 tumors
|
8 participants
n=5 Participants
|
|
Tumor burden per patient
3 tumors
|
4 participants
n=5 Participants
|
|
Tumor burden per patient
5 tumors
|
2 participants
n=5 Participants
|
|
Alpha Fetoprotein > 20 ng/ml
|
8 Participants
n=5 Participants
|
|
Prior Hepatocellular Carcinoma treatment
|
36 Participants
n=5 Participants
|
|
Within MIlan criteria
|
46 Participants
n=5 Participants
|
|
Tumor Size
|
2.73 centimeters
n=68 tumors
|
|
Biopsy Grade
well-differentiated
|
16 Participants
n=5 Participants
|
|
Biopsy Grade
moderately-differentiated
|
17 Participants
n=5 Participants
|
|
Biopsy Grade
poorly-differentiated
|
5 Participants
n=5 Participants
|
|
Biopsy Grade
not available (LIRADS 5)
|
19 Participants
n=5 Participants
|
|
Liver segment location
segment II
|
3 tumors
n=68 tumors
|
|
Liver segment location
segment III
|
13 tumors
n=68 tumors
|
|
Liver segment location
segment IV
|
7 tumors
n=68 tumors
|
|
Liver segment location
segment V
|
9 tumors
n=68 tumors
|
|
Liver segment location
segment VI
|
8 tumors
n=68 tumors
|
|
Liver segment location
segment VII
|
12 tumors
n=68 tumors
|
|
Liver segment location
segment VIII
|
16 tumors
n=68 tumors
|
PRIMARY outcome
Timeframe: 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)
Technical success is defined as the complete ablation of the target lesion (tumor and 5 mm margin), as determined by operator.
Outcome measures
| Measure |
Tumors Treated With Ablation Simulation Guidance.
n=68 tumors
The RFA Physics Library -- a Planning and Guidance Platform: Research software will be used during percutaneous liver RFA of HCC lesions \>2cm
|
|---|---|
|
Rate of Technical Success of Tumor Ablation
incomplete
|
0 tumors
|
|
Rate of Technical Success of Tumor Ablation
complete
|
68 tumors
|
PRIMARY outcome
Timeframe: 2 years after RFA treatmentPopulation: KM evaluation for proportion with local recurrence at 2-year follow-up
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.
Outcome measures
| Measure |
Tumors Treated With Ablation Simulation Guidance.
n=68 tumors
The RFA Physics Library -- a Planning and Guidance Platform: Research software will be used during percutaneous liver RFA of HCC lesions \>2cm
|
|---|---|
|
Rate of Local Tumor Recurrence
local recurrence at 2 years
|
9 tumors
|
|
Rate of Local Tumor Recurrence
no local recurrence at 2 years
|
59 tumors
|
Adverse Events
Ablation Simulation Guidance
Serious events: 2 serious events
Other events: 4 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Ablation Simulation Guidance
n=57 participants at risk
The RFA Physics Library -- a Planning and Guidance Platform software was used to provide ablation simulation guidance to support liver RFA of HCC lesions \>2cm
|
|---|---|
|
Injury, poisoning and procedural complications
hypotension
|
1.8%
1/57 • Number of events 1 • within 30 days of procedure
Adverse events were evaluated based on whether suspected/potentially related to the use of guidance software for the ablation versus the ablation procedure versus underlying patient disease/comorbidities. Adverse event collection based on patient clinical follow up during first month and then at 3 month clinic visits.
|
|
Nervous system disorders
hypoglycemia
|
1.8%
1/57 • Number of events 1 • within 30 days of procedure
Adverse events were evaluated based on whether suspected/potentially related to the use of guidance software for the ablation versus the ablation procedure versus underlying patient disease/comorbidities. Adverse event collection based on patient clinical follow up during first month and then at 3 month clinic visits.
|
Other adverse events
| Measure |
Ablation Simulation Guidance
n=57 participants at risk
The RFA Physics Library -- a Planning and Guidance Platform software was used to provide ablation simulation guidance to support liver RFA of HCC lesions \>2cm
|
|---|---|
|
Renal and urinary disorders
mild-moderate : urinary retention
|
7.0%
4/57 • Number of events 4 • within 30 days of procedure
Adverse events were evaluated based on whether suspected/potentially related to the use of guidance software for the ablation versus the ablation procedure versus underlying patient disease/comorbidities. Adverse event collection based on patient clinical follow up during first month and then at 3 month clinic visits.
|
Additional Information
Dr. Eric Hoffer, Director of Interventional Radiology
Dartmouth-Hitchcock Medical Center
Phone: 603 650 7417
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place