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

The University of Chicago

Status: Withdrawn

Conditions: Stage IB Breast Cancer; Stage IA Breast Cancer; Ductal Breast Carcinoma in Situ; Invasive Ductal Breast Carcinoma

Treatments: Procedure: magnetic resonance thermal imaging; Procedure: laser interstitial thermal therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01791998

12-1017

NCI-2013-00066 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: Female

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Treatment (MR-thermal image guided LITT)

Experimental group

Description:

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

Treatment:

Procedure: laser interstitial thermal therapy

Procedure: magnetic resonance thermal imaging