Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer

Study Overview
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Brief Summary
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This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue

Detailed Description
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PRIMARY OBJECTIVES: 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.

Official Title
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A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer

Conditions
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Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer

Intervention / Treatment
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* Procedure: magnetic resonance thermal imaging
* Procedure: laser interstitial thermal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal state 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: Previous surgery or radiation for the ipsilateral breast cancer 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (MR-thermal image guided LITT)<br>Patients undergo MR-thermal image guided LITT over 1 hour. | Procedure: magnetic resonance thermal imaging<br>* Undergo MR-thermal image guided LITT<br>Procedure: laser interstitial thermal therapy<br>* Undergo MR-thermal image guided LITT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of not completing the procedure due to patient's discomfort |  | Up to 7 days | 
| Observed thermal damage on skin | Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes. | Up to 7 days | 
| Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) |  | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of tumor necrosis |  | Up to 7 days | 
| Amount of viable tumor |  | Up to 7 days |