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.

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