NCT04152343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 7, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 21, 2024

Completed
Last Updated

May 21, 2024

Status Verified

April 1, 2024

Enrollment Period

3.1 years

First QC Date

November 2, 2019

Results QC Date

February 29, 2024

Last Update Submit

April 24, 2024

Conditions

Hepatocellular Carcinoma

Keywords

Radiofrequency Ablation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2 years after RFA treatment

Study Arms (1)

RFA Physics Library- PGP

EXPERIMENTAL

The RFA Physics Library will be used during during percutaneous liver RFA procedures.

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

Interventions

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

Research software used to support liver RFA of HCC lesions \>2cm

RFA Physics Library- PGP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Limitations and Caveats

Limited by no comparative cohort, small numbers (high drop out due to mortality before 2 yrs).

Results Point of Contact

Title
Dr. Eric Hoffer, Director of Interventional Radiology
Organization
Dartmouth-Hitchcock Medical Center
hoffer@hitchcock.org
603 650 7417

Study Officials

  • Eric K Hoffer, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Vascular and Interventional Radiology

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 5, 2019

Study Start

December 7, 2019

Primary Completion

December 30, 2022

Study Completion

March 31, 2023

Last Updated

May 21, 2024

Results First Posted

May 21, 2024

Record last verified: 2024-04

Locations

US(1)