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

This study is currently recruiting participants.
Verified March 2014 by University of Chicago
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01791998
First received: February 12, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 ]

Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (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:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791998

Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Hiroyuki Abe    773-702-2781    habe@radiology.bsd.uchicago.edu   
Principal Investigator: Hiroyuki Abe         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Hiroyuki Abe University of Chicago Comprehensive Cancer Center
  More Information

No publications provided

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

Additional relevant MeSH terms:
Carcinoma, Ductal, Breast
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma, Ductal

ClinicalTrials.gov processed this record on April 17, 2014