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


N/A
N/A
N/A
Open (Enrolling)
Female
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


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

Type of Study:

Interventional

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:

No

Principal Investigator

Hiroyuki Abe

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-1017

NCT ID:

NCT01791998

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

Name

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