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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is investigating a new, high-precision liver ablation technique to treat primary and secondary liver cancers. The technique includes stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of Life Questionnaire (EQ-5D-3L)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Liver ablationExperimental Treatment1 Intervention
The ablation procedure will be performed in 1 day
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,984 Previous Clinical Trials
1,789,037 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open enrollment opportunities for this research study?
"Confirmed. According to the clinicaltrials.gov website, this trial has ceased recruiting participants after it was posted on October 31st 2022 and last updated on May 4th 2022. Nevertheless, there are 1 other trials which are actively taking in patients at present."
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