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

This study has been withdrawn prior to enrollment.
(Funding was time sensitive and expired. No subjects enrolled.)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: February 12, 2013
Last updated: October 14, 2014
Last verified: October 2014
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

Condition Intervention
Ductal Breast Carcinoma in Situ
Invasive Ductal Breast Carcinoma
Stage IA Breast Cancer
Stage IB Breast Cancer
Procedure: magnetic resonance thermal imaging
Procedure: laser interstitial thermal therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Frequency of not completing the procedure due to patient's discomfort [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
  • Observed thermal damage on skin [ Time Frame: Up to 7 days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Up to 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Amount of tumor necrosis [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
  • Amount of viable tumor [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (MR-thermal image guided LITT)
Patients undergo MR-thermal image guided LITT over 1 hour.
Procedure: magnetic resonance thermal imaging
Undergo MR-thermal image guided LITT
Procedure: laser interstitial thermal therapy
Undergo MR-thermal image guided LITT

Detailed Description:


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 hour.

After completion of study treatment, patients are followed up at 3-7 days.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01791998

United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Principal Investigator: Hiroyuki Abe University of Chicago Comprehensive Cancer Center
  More Information

Responsible Party: University of Chicago Identifier: NCT01791998     History of Changes
Other Study ID Numbers: 12-1017  NCI-2013-00066 
Study First Received: February 12, 2013
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Breast Diseases
Carcinoma, Ductal
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases processed this record on May 24, 2016