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

Open (Enrolling)
Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer

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Trial Information

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


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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of not completing the procedure due to patient's discomfort

Outcome Time Frame:

Up to 7 days

Safety Issue:


Principal Investigator

Hiroyuki Abe

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2012

Completion Date:

August 2015

Related Keywords:

  • Ductal Breast Carcinoma in Situ
  • Invasive Ductal Breast Carcinoma
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast



University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470