Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05361551

Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)

Led by M.D. Anderson Cancer Center · Updated on 2026-04-17

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating a high-precision liver ablation technique for patients with primary and secondary liver cancers, specifically colorectal liver metastasis. This technique combines stereotactic guidance, CT imaging during hepatic arteriography, and computer-based software to assess ablation margins. The study aims to evaluate the technical effectiveness and local tumor progression-free survival of this combined method, addressing the need for accurate tumor boundary definition, probe placement, and margin assessment during ablation procedures. The treatment involves a one-day percutaneous liver ablation procedure where an image-guidance device is used for planning and precise placement of the ablation needle within the tumor. This combined approach integrates multiple steps previously used separately, aiming to improve ablation accuracy. The study will focus on various outcomes including minimal ablation margins, adverse events, liver function, tissue properties, radiation exposure, and overall oncological results. Participants will undergo assessments including quality of life evaluations using the EQ-5D-3L questionnaire throughout the study, averaging about one year. Researchers will monitor tumor response, adverse events, and other clinical measures to understand the treatment's impact. Safety and procedural times are also evaluated. The total participation duration covers the treatment day and follow-up assessments to track clinical outcomes and quality of life.

CONDITIONS

Brief Title

Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with up to 5 colorectal liver metastases measuring up to 5 cm referred for percutaneous ablation
  • Ability to cover the target tumor completely with at least a 5 mm ablation margin per imaging
  • Distance from tumor to central bile ducts greater than 1 cm
  • Adequate kidney function (GFR greater than 40) and no severe allergy to iodine contrast media
  • Ability to understand and sign informed consent
  • Age 18 years or older
  • Performance status 0 to 2 (ECOG classification)
  • Expected survival longer than 12 months
Not Eligible

You will not qualify if you...

  • Prior or concurrent local therapy at the target tumor(s)
  • Active bacterial or fungal infection on the day of ablation
  • Platelet count below 50,000/mm3
  • INR greater than 1.5
  • Uncorrectable blood clotting disorders
  • Pregnant or breastfeeding
  • Physical or psychological conditions that impair study participation
  • ASA score of 4 or higher
  • Any other loco-regional therapies at the target lesion(s)
  • Liver arterial blood supply variations preventing use of CT hepatic arteriography imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 day

Participants undergo imaging analysis using intra-arterial CT hepatic arteriography and computer-based software to assess ablation margins before the liver ablation procedure.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive stereotactic-guided percutaneous liver ablation with image-guided ablation needle placement and ablation confirmation.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants are followed up to evaluate technical efficacy, local tumor progression-free survival, quality of life, liver function, and oncological outcomes for up to 1 year.

Approximately 4 to 6 follow-up visits

Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

Loading map...

Research Team

B

Bruno Odisio, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Similar Trials

Comparison of Transcutaneous and Arterial Carbon Dioxide Mon...

Liver Ablation

Actively Recruiting

1 location

Artificial Intelligence to Predict Recurrence of Colorectal ...

Colorectal Liver Metastasis (CRLM)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Study Protocol STEREOLAB: Stereotactic Liver Ablation Assisted with Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment.

Iwan Paolucci, Jessica Albuquerque Marques Silva, Yuan-Mao Lin...

https://pubmed.ncbi.nlm.nih.gov/37563313