A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Chicago
- Locations
- 1
- Primary Endpoint
- Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Study Overview
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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment (MR-thermal image guided LITT)
Patients undergo MR-thermal image guided LITT over 1 hour.
Intervention: magnetic resonance thermal imaging (Procedure)
Treatment (MR-thermal image guided LITT)
Patients undergo MR-thermal image guided LITT over 1 hour.
Intervention: laser interstitial thermal therapy (Procedure)
Outcomes
Primary Outcomes
Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Time Frame: Up to 7 days
Frequency of not completing the procedure due to patient's discomfort
Time Frame: Up to 7 days
Observed thermal damage on skin
Time Frame: Up to 7 days
Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes.
Secondary Outcomes
- Amount of tumor necrosis(Up to 7 days)
- Amount of viable tumor(Up to 7 days)