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

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.

• magnetic resonance thermal imaging (Procedure): Undergo MR-thermal image guided LITT
• laser interstitial thermal therapy (Procedure): Undergo MR-thermal image guided LITT

Primary outcomes

• Frequency of not completing the procedure due to patient's discomfort [Up to 7 days]
• Observed thermal damage on skin [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) [Up to 7 days]

Secondary outcomes

• Amount of tumor necrosis [Up to 7 days]
• Amount of viable tumor [Up to 7 days]

Sex: Female

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

• Hiroyuki Abe, Principal investigator, University of Chicago Comprehensive Cancer Center