Trial Comparing PLA to HIGRT (PROVE-HCC)

NATerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 8, 2018

Primary Completion Date

July 25, 2019

Study Completion Date

March 25, 2020

Conditions
Hepatocellular Carcinoma
Interventions
PROCEDURE

Percutaneous Local Ablation

Microwave Ablation (MWA) is a form of percutaneous localized ablation using thermal ablation techniques to treat cancer via direct coagulative necrosis. Microwaves can generate high temperatures in a short period of time; MWA has the potential to improve treatment efficacy over radiofrequency ablation as it can be used to treat larger lesions and has less susceptibility to heat-sink due to vessel proximity. MWA uses electromagnetic waves (300 MHz to 300 GHz) to produce oscillation of polar molecules within tissue; this generates tissue necrosis through frictional heating. For HCC, one or more microwave antennae are inserted into the liver, usually under the guidance of ultrasonography or computed tomography (CT). Frequency and length of treatment is determined on a case by case basis depending on tumor size and proximity to vessels or other organs at risk.

RADIATION

Hypofractionated Image Guided Radiation Therapy

HIGRT represents the only non-invasive curative modality in the management of HCC. HCC patients typically have a host of other medical comorbidities complicated by underlying liver dysfunction that makes the implementation of liver-directed therapy challenging. Presently HIGRT is typically offered only after alternative surgical (transplantation/hepatectomy) and non-operative approaches (PLA/embolization) have been exhausted.

Trial Locations (2)

27705

Durham Veterans Administration Medical Center (DVAMC), Durham

27710

Duke Cancer Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Durham VA Medical Center

FED

collaborator

Hunter Holmes McGuire VA Medical Center

FED

lead

Duke University

OTHER

NCT03402607 - Trial Comparing PLA to HIGRT (PROVE-HCC) | Biotech Hunter | Biotech Hunter