Variability of Microwave Ablation Volume Based on Clinical, Radiological, Biological, and Tissue Factors

NCT07413640 | Recruiting

• 1 other identifier: 2025PI_230
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Neoplasm

Outcome Measures

Primary Outcomes (1)

• Small final ablation axis measured on the post-procedure imaging modality considered to be the most reliable.

  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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, F54511, France

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Valérie LAURENT, MD-PhD

CONTACT

33383157823; v.laurent@chru-nancy.fr

Astrée LEMORE, MD

CONTACT

33383157823; a.lemore@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-PhD

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

FR (1)