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New treatment option for Liver Ablation
Official title Stereotactic Liver Ablation Assisted With Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment (STEREOLAB)
ClinicalTrials.gov ID: NCT05361551
What this study is testing
- What it's testing
- To achieve adequate tumor treatment coverage with sufficient minimal ablation margins, several steps are required: firstly, it is critical to define tumor boundaries and extent on intra-procedural CT image; secondly, accurate planning, targeting, and confirmation of ablation probe placement within the tumor; thirdly, the use of an intra-procedural imaging assessment method to evaluate minimal ablation margins is required to define whether sufficient minimal ablation margins was obtained or if additional ablation is needed. Taking all together, those factors points to the need of having a high-precision ablation methodology for intra-procedural planning, monitoring, and ablation margin assessment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
- Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
- Distance to central bile ducts \> 1 cm;
- Adequate glomerular filtration rate (GFR \> 40) and no severe allergies to iodine contrast-media;
- Ability to understand and the willingness to sign written informed consent;
You likely can't join if
- Use of other prior or concomitant local therapy at the target tumor(s).
- Active bacterial infection or fungal infection on the day of the ablation.
- Platelet \< 50,000/mm3.
- INR \> 1.5
- Patients with uncorrectable coagulopathy.
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
See the full eligibility criteria
- Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
- Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
- Distance to central bile ducts \> 1 cm;
- Adequate glomerular filtration rate (GFR \> 40) and no severe allergies to iodine contrast-media;
- Ability to understand and the willingness to sign written informed consent;
- Age \> 18 years-old;
- Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG]);
- Expected survival \> 12 months.
- Use of other prior or concomitant local therapy at the target tumor(s).
- Active bacterial infection or fungal infection on the day of the ablation.
- Platelet \< 50,000/mm3.
- INR \> 1.5
- Patients with uncorrectable coagulopathy.
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
- Physical or psychological condition which would impair study participation.
- ASA (American Society of Anesthesiologists) score of ≥ 4.
- Any other loco-regional therapies at the target lesion(s).
- Anatomical variations in the arterial-hepatic blood supply of the liver that preclude the use of CTHA imaging.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.