Hepatocellular CarcinomaNCT04152343
An Intraoperative Guidance Platform for Radio Frequency Ablation
A study testing RFA Physics Library -- a Planning and Guidance Platform (PGP) in people with Hepatocellular Carcinoma, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. 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?
- RFA Physics Library -- a Planning and Guidance Platform (PGP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2019to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- ≥ 18 years of age
- Presence of hepatocellular carcinoma with a size equal or larger than 2cm.
- Scheduled for CT-guided thermal ablation under General Anesthesia
- Able to provide written, informed consent
Who cannot join
- Absolute of relative contraindication to MRI:
- the presence of an electronic implant, such as a pacemaker not approved for MRI
- the presence of a metal implant, such as an aneurysm clip not approved for MRI
- claustrophobia
- the presence of other contraindication(s), such as inability to comfortably lie flat, history of working with metal, other implanted hardware or shrapnel
- Target tumor adjacent to or within prior ablated or resected site.
- Serious psychiatric illness not adequately controlled to permit patient cooperation to obtain an MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the 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
- Conditions
- Hepatocellular Carcinoma
- Being tested
- RFA Physics Library -- a Planning and Guidance Platform (PGP)
- Keywords
- Radiofrequency Ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RFA Physics Library -- a Planning and Guidance Platform (PGP)Device
Research software used to support liver RFA of HCC lesions >2cm
| Study group | Role | What they receive |
|---|---|---|
| RFA Physics Library- PGP | Experimental | The RFA Physics Library will be used during during percutaneous liver RFA procedures. Receives: Device: RFA Physics Library -- a Planning and Guidance Platform (PGP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Success measured at end of RFA procedure, one-time event (lasting up to a few hours)
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.
Measured: 2 years after RFA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start7 Dec 2019
- Primary completion30 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eric K. Hoffer, Dartmouth-Hitchcock Medical Center
- Investigators
- Eric K Hoffer, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152343
- Sponsor's protocol ID
- SF19108
- Other IDs
- 2R44CA189515
- Status last verified
- Apr 2024
- First submitted
- 2 Nov 2019
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intraoperative Guidance Platform for Radio Frequency Ablation
- ClinicalTrials.gov ID
- NCT04152343
- Acronym / sponsor ID
- SF19108
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Dec 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFA Physics Library- PGP | Experimental | Device: RFA Physics Library -- a Planning and Guidance Platform (PGP)The RFA Physics Library will be used during during percutaneous liver RFA procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Presence of hepatocellular carcinoma with a size equal or larger than 2cm.
- Scheduled for CT-guided thermal ablation under General Anesthesia
- Able to provide written, informed consent
Key exclusion criteria (7 listed)
- Absolute of relative contraindication to MRI:
- Target tumor adjacent to or within prior ablated or resected site.
- Serious psychiatric illness not adequately controlled to permit patient cooperation to obtain an MRI
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 |
|---|---|---|
| RFA Physics Library -- a Planning and Guidance Platform (PGP)Research software used to support liver RFA of HCC lesions >2cm | Device | RFA Physics Library- PGP |
Primary outcome
Rate of Technical Success of Tumor Ablation
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Eric K Hoffer, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RFA Physics Library -- a Planning and Guidance Platform (PGP) in people with Hepatocellular Carcinoma, run by Dartmouth-Hitchcock Medical Center 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 21 May 2024. 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?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Technical Success of Tumor Ablation (time frame: Success measured at end of RFA procedure, one-time event (lasting up to a few hours)). The study lists 2 primary outcomes in all. 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 21 May 2024.