Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer
Conditions
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.
Interventions
PROCEDUREmagnetic resonance thermal imaging
Undergo MR-thermal image guided LITT
PROCEDURElaser interstitial thermal therapy
Undergo MR-thermal image guided LITT
Sponsors
National Cancer Institute (NCI)
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) | Up to 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of tumor necrosis | Up to 7 days |
| Amount of viable tumor | Up to 7 days |
Countries
United States
Outcome results
None listed