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

The University of Chicago logo

The University of Chicago

Status

Withdrawn

Conditions

Stage IB Breast Cancer
Stage IA Breast Cancer
Ductal Breast Carcinoma in Situ
Invasive Ductal Breast Carcinoma

Treatments

Procedure: magnetic resonance thermal imaging
Procedure: laser interstitial thermal therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01791998
12-1017
NCI-2013-00066 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

  1. 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.

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Treatment (MR-thermal image guided LITT)
Experimental group
Description:
Patients undergo MR-thermal image guided LITT over 1 hour.
Treatment:
Procedure: laser interstitial thermal therapy
Procedure: magnetic resonance thermal imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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