Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer
|Ductal Breast Carcinoma in Situ Invasive Ductal Breast Carcinoma Stage IA Breast Cancer Stage IB Breast Cancer||Procedure: magnetic resonance thermal imaging Procedure: laser interstitial thermal therapy|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer|
- Frequency of not completing the procedure due to patient's discomfort [ Time Frame: Up to 7 days ]
- Observed thermal damage on skin [ Time Frame: Up to 7 days ]Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes.
- Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) [ Time Frame: Up to 7 days ]
- Amount of tumor necrosis [ Time Frame: Up to 7 days ]
- Amount of viable tumor [ Time Frame: Up to 7 days ]
|Study Start Date:||August 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (MR-thermal image guided LITT)
Patients undergo MR-thermal image guided LITT over 1 hour.
Procedure: magnetic resonance thermal imaging
Undergo MR-thermal image guided LITTProcedure: laser interstitial thermal therapy
Undergo MR-thermal image guided LITT
I. To evaluate the procedural success rate of using the Visualase magnetic resonance (MR)-guided laser system to target, access, thermally monitor, and focally ablate MR-visible breast cancer lesions.
2. To obtain preliminary data on ablative success using pathologic assessment for specimen excised subsequent to the ablation.
Patients undergo MR-thermal image guided laser interstitial thermal therapy (LITT) over 1 hour.
After completion of study treatment, patients are followed up at 3-7 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791998
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Hiroyuki Abe||University of Chicago Comprehensive Cancer Center|