MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas

Stopped early · Phase 3

Conditions studied: Breast Fibroadenoma

In brief

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.

Key facts

Study ID

NCT00147108

Run by

InSightec

People needed

102

Starts

2003-01-01

Expected to finish

2005-10-01

Last updated by the study team

2012-09-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University MRI — Boca Raton, Florida, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Virtua — Voorhees Township, New Jersey, United States
• Cornell Vascular — New York, New York, United States
• Breastopia Namba Hospital — Miyazaki-ken, Japan

Full record on ClinicalTrials.gov

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