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MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

NCT00147108 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2012-09-17

No results posted yet for this study

Summary

The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a. lead to a decrease in lesion cross-sectional area of \> 50% on palpation, and \>65% in lesion volume as measured by MRI (both calculations assume an elliptical shape of the lesion in all 3 dimensions). b. this decrease in size, along with the softening of the treated volume will result in satisfactory clinical results in greater than 50 % of the patients.

Conditions

  • Breast Fibroadenoma

Interventions

DEVICE

ExAblate 2000

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Clare Tempany, M.D. · Brigham and Women's Hospital

  • Robert Min, M.D. · Cornell Vascular

  • Fred Steinberg, M.D. · University MRI

  • Mark DeLaurentis, M.D. · Virtua

  • Hidemi Furusawa, M.D. · Breastopia Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2005-08-31
Completion
2005-10-31

Countries

  • United States
  • Japan

Study Locations

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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 NCT00147108 on ClinicalTrials.gov