MR-Guided Laser Ablation of Hepatic Tumors
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: 0 What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 09-000864
NCT ID: NCT01630239
Sponsor Protocol Number: 09-000864
About this study
This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Patients with soft tissue tumor metastases to the liver who are referred to Interventional Radiology for treatment.
- Surgery is not a viable or desirable alternative therapy at the time of enrollment
- Radiation therapy has failed or not indicated or can be safely postponed
- Tumor size ≤ 5 cm at its largest diameter
- Tumor position is not in the central liver hilum
- Performance status is ECOG 2 or better in adults
- Patient is able to undergo MRI
- Patients with pacemaker or defibrillator
- Patients with metallic surgical clips close to the site of the intended ablation
- Pregnant women
- Patients with hilar liver lesions
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.