What side effects are associated with this type of intervention?

Common side effects of liver ablation treatments, including high-precision techniques like stereotactic guidance combined with CT hepatic arteriography and computer-based software, generally include pain at the treatment site, fever, and post-ablation syndrome characterized by flu-like symptoms. More serious but less common side effects can include bleeding, infection, and damage to surrounding organs or tissues. Specific to high-precision techniques, the use of advanced imaging and software aims to minimize these risks by ensuring accurate targeting and adequate ablation margins.

What prior FDA approvals exist?

The FDA has approved several technologies and drugs for liver ablation, including radiofrequency ablation (RFA), microwave ablation (MWA), and stereotactic body radiation therapy (SBRT). These treatments are used to target and destroy liver tumors with precision. For instance, stereotactic guidance and advanced imaging techniques like CT during hepatic arteriography are employed to enhance the accuracy of ablation procedures. Additionally, computer-based software for ablation margin assessment is increasingly being integrated to ensure complete tumor coverage and improve outcomes. While specific drugs are not typically used in the ablation process itself, they may be part of combination therapies to enhance the overall treatment efficacy.

What other types of research exist?

Promising alternatives to the High-Precision Liver Ablation Technique for liver ablation patients in 2024 include: 1) Yttrium-90 Radioembolization, which uses radioactive microspheres to target liver tumors with high precision and has shown positive outcomes in various studies. 2) Transarterial Chemoembolization (TACE), particularly when combined with other modalities like microwave ablation or radiotherapy, offering enhanced efficacy for large or multinodular hepatocellular carcinomas. 3) Stereotactic Body Radiotherapy (SBRT), which provides high-dose radiation with precise targeting, beneficial for patients with portal vein thrombosis or those unsuitable for other interventions.

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Procedure

Stereotactic Liver Ablation for Liver Cancer

N/A

Recruiting

Led By Bruno Odisio, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation

Distance to central bile ducts > 1 cm

Must not have

Active bacterial infection or fungal infection on the day of the ablation

Patients with uncorrectable coagulopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates a high-precision liver ablation technique for patients with colorectal liver metastasis. The method uses advanced imaging and computer software to accurately target and destroy tumors, ensuring complete treatment.

Who is the study for?

The STEREOLAB trial is for adults over 18 with up to five liver tumors from colorectal cancer, each no larger than 5 cm. They must be able to undergo a precise ablation treatment and have a life expectancy of more than a year. Participants need good kidney function, no severe iodine allergies, and can't be too close to vital bile ducts or severely ill based on specific health scores.

What is being tested?

This study tests a high-precision liver ablation technique using stereotactic guidance, CT imaging during hepatic arteriography, and software for assessing if the tumor's been fully treated. It aims to see how well this combined method works in treating primary and secondary liver cancers.

What are the potential side effects?

While not explicitly listed in the provided information, typical side effects of liver ablation procedures may include pain at the site of treatment, bleeding internally or externally, infection risks at the probe insertion point, damage to nearby organs or structures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have up to 5 liver tumors from colorectal cancer, each no larger than 5 cm, and am referred for a specific tumor-removal procedure.

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My bile duct condition is more than 1 cm away from the central bile ducts.

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I am older than 18 years.

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I can take care of myself and perform daily activities.

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My kidneys work well and I'm not severely allergic to iodine-based dyes.

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My tumor can be fully treated with a margin of safety.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active bacterial or fungal infection.

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My blood does not clot properly and cannot be corrected.

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My liver's blood supply prevents me from having a specific liver imaging test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Life Questionnaire (EQ-5D-3L)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Liver ablationExperimental Treatment1 Intervention

The ablation procedure will be performed in 1 day

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Liver ablation treatments, such as the high-precision technique combining stereotactic guidance, CT during hepatic arteriography, and computer-based software for ablation margin assessment, work by accurately targeting and destroying liver tumors. Stereotactic guidance ensures precise probe placement, while CT during hepatic arteriography provides detailed imaging of the tumor and surrounding vasculature. The computer-based software assesses ablation margins to confirm complete tumor coverage. This precision minimizes damage to healthy tissue, reduces complications, and improves treatment efficacy, which is crucial for liver ablation patients seeking effective and safe tumor eradication.