NCT01791998

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

1.8 years

First QC Date

February 12, 2013

Last Update Submit

October 14, 2014

Conditions

Ductal Breast Carcinoma in SituInvasive Ductal Breast CarcinomaStage IA Breast CancerStage IB Breast Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Amount of tumor necrosis

    Up to 7 days

  • Amount of viable tumor

    Up to 7 days

Study Arms (1)

Treatment (MR-thermal image guided LITT)

EXPERIMENTAL

Patients undergo MR-thermal image guided LITT over 1 hour.

Procedure: magnetic resonance thermal imagingProcedure: laser interstitial thermal therapy

Interventions

magnetic resonance thermal imagingPROCEDURE

Undergo MR-thermal image guided LITT

Treatment (MR-thermal image guided LITT)
laser interstitial thermal therapyPROCEDURE

Undergo MR-thermal image guided LITT

Treatment (MR-thermal image guided LITT)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, NoninfiltratingCarcinoma, Ductal, BreastBreast Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, DuctalNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hiroyuki Abe

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 15, 2013

Study Start

August 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

US(1)