Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer
NCT ID: NCT01791998
Last Updated: 2014-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2012-08-31
2014-06-30
Brief Summary
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Detailed Description
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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.
OUTLINE:
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (MR-thermal image guided LITT)
Patients undergo MR-thermal image guided LITT over 1 hour.
magnetic resonance thermal imaging
Undergo MR-thermal image guided LITT
laser interstitial thermal therapy
Undergo MR-thermal image guided LITT
Interventions
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magnetic resonance thermal imaging
Undergo MR-thermal image guided LITT
laser interstitial thermal therapy
Undergo MR-thermal image guided LITT
Eligibility Criteria
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Inclusion Criteria
* Histological diagnosis of breast invasive ductal carcinoma with receptor profiles obtained
* MRI visible breast lesion
* Unifocal cancer, less than 1.5 cm in maximum diameter (clinical stage T1), with no evidence of extensive in situ cancer surrounding the main tumor; the eligibility will be determined by the MR imaging appearance of the tumor; if the tumor (proven invasive ductal carcinoma) is a unifocal mass without additional enhancement, it will be judged eligible; however, if the tumor is associated with additional enhancement and/or a satellite focus, it will not judged ineligible, as these are signs of additional in situ or invasive cancer
* Clinical stage N0 (no metastatic axillary lymph node on physical examination or imaging work-up)
* Ability to give informed consent
Exclusion Criteria
* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
* Tumor located less than 1 cm from the skin or the pectoralis muscle
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Hiroyuki Abe
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Comprehensive Cancer Center
Locations
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University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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NCI-2013-00066
Identifier Type: REGISTRY
Identifier Source: secondary_id
12-1017
Identifier Type: -
Identifier Source: org_study_id
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