NCT04152343

An Intraoperative Guidance Platform for Radio Frequency Ablation

Completed NA Results posted Last updated 21 May 2024

What this trial tests

NA trial testing RFA Physics Library -- a Planning and Guidance Platform (PGP) in Hepatocellular Carcinoma in 62 participants. Completed in 31 March 2023.

Timeline

7 December 2019

Primary endpoint
30 December 2022

31 March 2023

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	7 December 2019
Primary completion	30 December 2022
Estimated completion	31 March 2023
Sites	1 location across United States

Drugs / interventions tested

• RFA Physics Library -- a Planning and Guidance Platform (PGP)

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Technical Success of Tumor Ablation Primary · 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.

Group	Value	95% CI
Tumors Treated With Ablation Simulation Guidance.	68
Tumors Treated With Ablation Simulation Guidance.	0

Rate of Local Tumor Recurrence Primary · 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.

Group	Value	95% CI
Tumors Treated With Ablation Simulation Guidance.	9
Tumors Treated With Ablation Simulation Guidance.	59

Adverse events — posted to ClinicalTrials.gov

Time frame: within 30 days of procedure. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ablation Simulation Guidance

Serious: 2/57 (4%)

Deaths: 20/57

Serious adverse events (2 terms)

Reaction	System	Ablation Simulation Guidance
hypotension	Injury, poisoning and procedural complications	—
hypoglycemia	Nervous system disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Ablation Simulation Guidance
mild-moderate : urinary retention	Renal and urinary disorders	—

Most-reported serious reactions: hypotension, hypoglycemia.

Data from ClinicalTrials.gov NCT04152343 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ablation margin quantification after thermal ablation of malignant liver tumors: How to optimize the procedure? A systematic review of the available evidence.
   Hendriks P, Boel F, Oosterveer TT, Broersen A, et al · · 2023 · cited 9× · PMID 37405153 · DOI 10.1016/j.ejro.2023.100501