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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 belowSelect...
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.
Select...
My bile duct condition is more than 1 cm away from the central bile ducts.
Select...
I am older than 18 years.
Select...
I can take care of myself and perform daily activities.
Select...
My kidneys work well and I'm not severely allergic to iodine-based dyes.
Select...
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:Select...
I do not have an active bacterial or fungal infection.
Select...
My blood does not clot properly and cannot be corrected.
Select...
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
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
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.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,051 Previous Clinical Trials
1,798,807 Total Patients Enrolled
Bruno Odisio, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.My bile duct condition is more than 1 cm away from the central bile ducts.I do not have an active bacterial or fungal infection.I am older than 18 years.I have used other treatments directly on my tumor.My blood does not clot properly and cannot be corrected.I have not had treatments directly on the cancer spots.My liver's blood supply prevents me from having a specific liver imaging test.I can take care of myself and perform daily activities.My kidneys work well and I'm not severely allergic to iodine-based dyes.My tumor can be fully treated with a margin of safety.
Research Study Groups:
This trial has the following groups:- Group 1: Liver ablation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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