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Status:

TERMINATED

MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

Lead Sponsor:

InSightec

Conditions:

Breast Fibroadenoma

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief 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 ...

Detailed Description

Many patients are now diagnosed with breast fibroadenomas. These are generally detected during breast self-exams, or annual physicals as a smooth, rubbery, oval/elliptical lump in the breast. These pa...

Eligibility Criteria

Inclusion

  • Gender: Females only
  • Histologic confirmation of breast fibroadenoma by large core (needle gauge range 11-14 ) biopsy.
  • Single tumor per breast quadrant
  • Tumor clearly visible on non-contrast MRI
  • Age \> 18 years 3.2.6 Signed informed consent
  • Tumor 5 mm or larger as measured on pre-treatment MR.

Exclusion

  • Gender: male
  • Focal breast lesion on MRI over 3.5 cm as evaluated by MRI
  • Distance from the edge of the breast fibroadenoma to the skin less than 0.5-cm or ribs less than 1 cm.
  • Microcalcifications within the lesion
  • Known intolerance to the MRI contrast agent (Gadolinium or Magnevist) 3.3.6 Patients on dialysis.
  • Hemolytic anemia (hematocrit\<30)
  • Patients with unstable cardiac status including: Unstable angina pectoris on medication Patients with documented myocardial infarction within six months of protocol entry Congestive heart failure requiring medication (other than diuretic) Patients on anti-arrhythmic drugs Severe hypertension (diastolic BP \> 100 on medication)
  • Patients with cardiac pacemakers
  • ASA Score\>2
  • Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 3.3.12 Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.) 3.3.13 Patients with breast implants
  • Large patients who cannot fit in the magnet (weight\>250 pounds), and patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices
  • Patients on anti-coagulation therapy, or those with an underlying bleeding disorder.
  • Patient has a prior history of breast cancer
  • Patient has a prior history of laser or radiation therapy to the target breast
  • Patient has a prior history of chemo therapy

Key Trial Info

Start Date :

January 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2005

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT00147108

Start Date

January 1 2003

End Date

October 1 2005

Last Update

September 17 2012

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

University MRI

Boca Raton, Florida, United States, 33431

2

Brigham & Women's Hospital

Boston, Massachusetts, United States, 02115

3

Virtua

Voorhees Township, New Jersey, United States, 08043

4

Cornell Vascular

New York, New York, United States, 10022