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

Not Applicable

Withdrawn

• Conditions: Invasive Ductal Breast Carcinoma; Stage IB Breast Cancer; Ductal Breast Carcinoma in Situ; Stage IA Breast Cancer
• Interventions: Procedure: magnetic resonance thermal imaging; Procedure: laser interstitial thermal therapy

• Registration Number: NCT01791998
• Lead Sponsor: University of Chicago

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-02-12
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (MR-thermal image guided LITT)	magnetic resonance thermal imaging	Patients undergo MR-thermal image guided LITT over 1 hour.
Treatment (MR-thermal image guided LITT)	laser interstitial thermal therapy	Patients undergo MR-thermal image guided LITT over 1 hour.

Primary Outcome Measures

Name	Time	Method
Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)	Up to 7 days
Frequency of not completing the procedure due to patient's discomfort	Up to 7 days
Observed thermal damage on skin	Up to 7 days	Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes.

Secondary Outcome Measures

Name	Time	Method
Amount of tumor necrosis	Up to 7 days
Amount of viable tumor	Up to 7 days

Trial Locations

Locations (1)

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States