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MRI in Predicting Tumor Reponse After Radiofrequency Ablation in Women With Invasive Breast Cancer

NCT00373152 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2017-12-05

No results posted yet for this study

Summary

RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well radiofrequency ablation works to kill breast cancer cells and help doctors predict whether breast cancer cells remain after treatment.

PURPOSE: This phase II trial is studying how well MRI works in predicting tumor response after radiofrequency ablation in women with invasive breast cancer.

Conditions

Interventions

PROCEDURE

Lumpectomy

Standard lumpectomy or mastectomy will be performed 1 to 21 days after the post-RFA MRI.

PROCEDURE

dynamic contrast-enhanced magnetic resonance imaging

Dynamic-contrast enhanced breast images will be visualized with parametric image maps to assist in identifying regions with residual cancer.

PROCEDURE

radiofrequency ablation

RFA is accomplished by placing a multi-array needle within a tumor. The tines of the needle are advanced and opened like an inverted umbrella. High frequency, alternating current moves from the tip of an electrode into the surrounding tissue. Oscillating ions generate frictional heat within the tumor. Cell death occurs at sustained temperatures above 45-50 degrees C. The multi-array configuration creates an egg-shaped ablation zone up to 5 cm in diameter.

RADIATION

gadopentetate dimeglumine

Injected at baseline MRI and post radiofrequency ablation MRI.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Todd M. Tuttle, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00373152 on ClinicalTrials.gov