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

Primary Purpose

Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Stage IA Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
magnetic resonance thermal imaging
laser interstitial thermal therapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductal Breast Carcinoma in Situ

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (MR-thermal image guided LITT)

Arm Description

Patients undergo MR-thermal image guided LITT over 1 hour.

Outcomes

Primary Outcome Measures

Frequency of not completing the procedure due to patient's discomfort
Observed thermal damage on skin
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)

Secondary Outcome Measures

Amount of tumor necrosis
Amount of viable tumor

Full Information

First Posted
February 12, 2013
Last Updated
October 14, 2014
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01791998
Brief Title
Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer
Official Title
A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Funding was time sensitive and expired. No subjects enrolled.
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (MR-thermal image guided LITT)
Arm Type
Experimental
Arm Description
Patients undergo MR-thermal image guided LITT over 1 hour.
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance thermal imaging
Intervention Description
Undergo MR-thermal image guided LITT
Intervention Type
Procedure
Intervention Name(s)
laser interstitial thermal therapy
Intervention Description
Undergo MR-thermal image guided LITT
Primary Outcome Measure Information:
Title
Frequency of not completing the procedure due to patient's discomfort
Time Frame
Up to 7 days
Title
Observed thermal damage on skin
Description
Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes.
Time Frame
Up to 7 days
Title
Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Amount of tumor necrosis
Time Frame
Up to 7 days
Title
Amount of viable tumor
Time Frame
Up to 7 days

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroyuki Abe
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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