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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00066 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Funding was time sensitive and expired. No subjects enrolled.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (MR-thermal image guided LITT) | Experimental | Patients undergo MR-thermal image guided LITT over 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance thermal imaging | Procedure | Undergo MR-thermal image guided LITT |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of not completing the procedure due to patient's discomfort | Up to 7 days | |
| Observed thermal damage on skin | Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes. | Up to 7 days |
| Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of tumor necrosis | Up to 7 days | |
| Amount of viable tumor | Up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroyuki Abe | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637-1470 | United States |
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| laser interstitial thermal therapy | Procedure | Undergo MR-thermal image guided LITT |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044584 | Carcinoma, Ductal |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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