Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01791998|
Recruitment Status : Withdrawn (Funding was time sensitive and expired. No subjects enrolled.)
First Posted : February 15, 2013
Last Update Posted : October 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|