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Procedure

Echo-Guided Radiofrequency Ablation for Liver Cancer

N/A
Recruiting
Led By T. Douglas Mast, PhD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Scheduled for resection of at least one confirmed primary or metastatic liver tumor with estimated diameter <5 cm at the University of Cincinnati Medical Center (UCMC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test whether using echo decorrelation to guide radiofrequency ablation can ensure complete tumor destruction while sparing healthy tissue.

Who is the study for?
This trial is for adults over 18 with liver tumors smaller than 5 cm, who are scheduled for tumor resection at UCMC. It's open to those with additional conditions like cirrhosis or hepatitis and willing to consent to the study. People can't join if their tumor has been previously treated, is larger than 5 cm, or if RFA poses safety risks.Check my eligibility
What is being tested?
The study tests a new way of controlling Radiofrequency Ablation (RFA) using echo decorrelation imaging versus standard methods in treating liver tumors. The goal is to see if this new method can predict and ensure complete ablation of liver cancer effectively during surgery.See study design
What are the potential side effects?
While specific side effects aren't listed, RFA procedures may include pain at the treatment site, infection risk, bleeding, damage to nearby organs or structures due to heat exposure from the ablation process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for liver tumor surgery at UCMC for a tumor smaller than 5 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ablation volumes
Area under ROC curves
Conformity with planned ablation zone
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: arm 2: imaging-controlled RFAExperimental Treatment1 Intervention
In up to 6 additional patients (arm 2: imaging-controlled RFA), real-time, 3D echo decorrelation imaging during ablation will provide an additional treatment end point.
Group II: arm 1: generator-controlled RFAExperimental Treatment1 Intervention
In up to 6 patients (arm 1: generator-controlled RFA), RFA will be performed directly following manufacturer-specified algorithms, with recording of 3D ultrasound echo decorrelation images during ablation.

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,382 Total Patients Enrolled
T. Douglas Mast, PhDPrincipal InvestigatorUniversity of Cincinnati

Media Library

RFA controlled using echo decorrelation imaging (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05211388 — N/A
Liver Cancer Research Study Groups: arm 2: imaging-controlled RFA, arm 1: generator-controlled RFA
Liver Cancer Clinical Trial 2023: RFA controlled using echo decorrelation imaging Highlights & Side Effects. Trial Name: NCT05211388 — N/A
RFA controlled using echo decorrelation imaging (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05211388 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being actively sought for this investigation?

"Affirmative. Clinicaltrials.gov data verifies that this clinical trial, initially posted on July 11th 2022, is actively recruiting participants. The study requires 12 individuals from one medical facility to partake in the research."

Answered by AI

How many individuals can enroll in this experiment?

"Affirmative, the data on clinicaltrials.gov attests that this investigation is presently recruiting participants. The trial was first published on July 11th 2022 and underwent its most recent update 12 days later. This research requires a total of 12 subjects to be recruited from one medical facility."

Answered by AI
~1 spots leftby Jul 2024