NCT00147108

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 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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2003

Typical duration for phase_3

Geographic Reach
2 countries

5 active sites

Status
terminated

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

January 1, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 17, 2012

Status Verified

September 1, 2012

Enrollment Period

2.6 years

First QC Date

September 2, 2005

Last Update Submit

September 13, 2012

Conditions

Breast Fibroadenoma

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • treatment/ablation of breast fibroadenoma

Interventions

ExAblate 2000DEVICE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University MRI

Boca Raton, Florida, 33431, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Virtua

Voorhees Township, New Jersey, 08043, United States

Location

Cornell Vascular

New York, New York, 10022, United States

Location

Breastopia Namba Hospital

Miyazaki-ken, 880-0052, Japan

Location

Related Links

MeSH Terms

Conditions

FibroadenomaBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clare Tempany, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Robert Min, M.D.

    Cornell Vascular

    PRINCIPAL INVESTIGATOR

  • Fred Steinberg, M.D.

    University MRI

    PRINCIPAL INVESTIGATOR

  • Mark DeLaurentis, M.D.

    Virtua

    PRINCIPAL INVESTIGATOR

  • Hidemi Furusawa, M.D.

    Breastopia Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

January 1, 2003

Primary Completion

August 1, 2005

Study Completion

October 1, 2005

Last Updated

September 17, 2012

Record last verified: 2012-09

Locations

JP(1)US(4)