Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04152343
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2019-11-02
Brief Title:
An Intraoperative Guidance Platform for Radio Frequency Ablation
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
An Intraoperative Guidance Platform for Radio Frequency Ablation
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oct2910e219-e227 doi 101016jacra202112018 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 manufacturers protocol Target tumor 5 mm margin Planning targeting intraprocedural repositioning assessment of ablation coverage using software simulation in conjunction with manufacturers 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
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 Oct2910e219-e227 doi 101016jacra202112018 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 manufacturers protocol Target tumor 5 mm margin Planning targeting intraprocedural repositioning assessment of ablation coverage using software simulation in conjunction with manufacturers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R44CA189515 | NIH | None | httpsreporternihgovquickSearch2R44CA189515 |