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

Stage IB Breast Cancer Clinical Trial

Official title:

A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01791998
• Other study ID #: 12-1017
• Secondary ID: NCI-2013-00066
• Status: Withdrawn
• Phase: N/A
• First received: February 12, 2013
• Last updated: October 14, 2014
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Breast Carcinoma in Situ
• Invasive Ductal Breast Carcinoma
• Stage IA Breast Cancer
• Stage IB Breast Cancer

Intervention

Procedure:
• magnetic resonance thermal imaging
Undergo MR-thermal image guided LITT
• laser interstitial thermal therapy
Undergo MR-thermal image guided LITT

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of not completing the procedure due to patient's discomfort		Up to 7 days	No
Primary	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	Yes
Primary	Grade 3 or 4 toxicities assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)		Up to 7 days	Yes
Secondary	Amount of tumor necrosis		Up to 7 days	No
Secondary	Amount of viable tumor		Up to 7 days	No