Clinical trial NCT01791998: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Ductal Breast Carcinoma in Situ
Invasive Ductal Breast Carcinoma
Stage IA Breast Cancer
Stage IB Breast Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-02-15
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of not completing the procedure due to patient's discomfort
timeFrame: Up to 7 days
measure: Observed thermal damage on skin
timeFrame: Up to 7 days
measure: Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
timeFrame: Up to 7 days
Secondary outcomes:
measure: Amount of tumor necrosis
timeFrame: Up to 7 days
measure: Amount of viable tumor
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Hiroyuki Abe
role: PRINCIPAL_INVESTIGATOR
References: