A Phase 4 interventional study of Laser Ablation and Magnetic Resonance Thermal Imaging in Advanced Cancer and Bone Metastases, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-15.
Sponsored by M.D. Anderson Cancer Center · Phase 4, Interventional, and Treatment
The goal of this clinical research study is to learn how well magnetic resonance thermal imaging (MRTI) can check the amount of tumor being destroyed using a therapy called laser ablation (a procedure that uses lasers to create heat that is designed to destroy cancer cells).
Laser ablation is designed to destroy tumor tissue with the use of fiber optics that are placed directly into the tumor to deliver laser light energy into the tissue.
In this study, tumor destruction will be checked using MRTI. MRTI is very similar to other MRI techniques, but instead of providing imaging data, MRTI will provide temperature data for cancerous areas in the body during the laser ablation process. If tumor temperature can be measured more accurately, the laser ablation process may be safer.
Laser Ablation and the MRTI Scan:
If you are found to be eligible to take part in this study, on the day you have laser ablation, you will have an intravenous (IV) line placed. You will receive sedation or general anaesthesia (drugs to make you sleep) through a needle in your vein over 1-3 hours to lessen any pain you may have during the procedure. This process will be explained to you.
After receiving the anaesthesia, the following tests and procedures will be performed:
After the procedure is completed, you will be kept in the hospital for 4-6 hours for observation. You will be checked for recovery from the sedation that you received during the procedure. Once you have recovered from the procedure, you will be allowed to leave the hospital. If you have side effects from the procedure, the doctor may decide to keep you in the hospital for a longer time period for observation.
Follow-Up Visits:
After you have completed the procedure, you will return to M. D. Anderson for follow-up visits. About one (1) week after the laser ablation, you will have a physical exam and an X-ray. About one (1) month after the laser ablation, you will have a physical exam and a limited MRI to check the status of the disease.
Length of Study:
You will be considered off-study after the 1-month follow up visit.
This is an investigational study. The laser ablation procedure is an FDA-approved procedure. The devices are commercially available and can be used outside research studies. The investigational part of this study involves using MRTI to check the effect of ablation on the tumor. Up to 24 participants will be enrolled in this study. All will be enrolled at M.D. Anderson.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 24 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Magnetic resonance thermal imaging = MRTI
Procedure: Laser Ablation · Procedure: Magnetic Resonance Thermal Imaging
Laser ablation procedure taking about 1-3 hours, depending on the size and location of the tumor.
MRTI will be used to monitor the temperature within the ablation zone during the laser ablation.
Also known as: MRTI
Correlation of Maximal Dimensions of 60-degree Celsius Isotherm + Ablation Zone Dimensions as determined by MRI
Magnetic resonance thermal imaging (MRTI) data to determine the correlation between observed temperatures determined from MRTI and the actual size of ablation as determined by post-ablation contrast-enhanced magnetic resonance imaging (MRI) during Laser Induced Thermal Therapy (LITT) of soft tissue metastases in bone.
Time frame: 2 Years
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center