Variability of Microwave Ablation Volume Based on Clinical, Radiological, Biological, and Tissue Factors (MICRO-VAR)

February 24, 2026 updated by: Valérie LAURENT, Central Hospital, Nancy, France

Variability of Microwave Ablation Volume Based on Clinical, Radiological, Biological, and Tissue Factors : a Retrospective Study

Microwave ablation is a minimally invasive technique whose planning relies on manufacturer tables derived from ex vivo models that do not account for patient or tumor-specific factors. In clinical practice, the actual ablation volume often differs from the planned volume due to liver characteristics, vascular proximity, and tumor biology.

This study aims to assess the variability between ablation small axis during percutaneous microwave ablation of liver lesions. The influence of patient-related (fibrosis, steatosis, portal flow) and tumor-related factors (location, histology, prior treatment) will be evaluated. Small axis and volume will be compared with volumes measured on immediate post-procedural CT and on CT/MRI at 6-12 weeks, accounting for expected tissue shrinkage.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients treated with percutaneous hepatic microwave ablation under CT or ultrasound guidance for one or more liver lesions with followed up imaging availables

Description

Inclusion Criteria:

  • Adult patients
  • Treated with percutaneous hepatic microwave ablation under CT or ultrasound guidance
  • Adult treated for one or more liver lesions
  • Patients with available follow-up imaging

Exclusion Criteria:

  • Two treatment cycles on the same lesion during the same session.
  • Reoperation on the same lesion.
  • Planned volume not available (no manufacturer data, not specified in the surgical report).
  • No control imaging injected between 1 and 4 months post-procedure.
  • Final ablation volume not measurable (e.g., artifacts, no injection on MRI).
  • No definitive diagnosis of the nature of the tumor on imaging and no histology available.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small final ablation axis measured on the post-procedure imaging modality considered to be the most reliable.
Time Frame: 12 weeks
The final short axis will preferably be measured (in mm) on MRI at 6-12 weeks. If inter-patient variability in volume shrinkage exceeds 5%, the modality with the lowest relative variability (usually the immediate CT scan) will be used as the reference for estimating the final volume.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025PI_230

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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