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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00147108 |
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Date of registration:
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02/09/2005 |
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Primary sponsor: |
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Public title:
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MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
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Scientific title:
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Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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102 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00147108 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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United States
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Contacts
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Name:
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Hidemi Furusawa, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Breastopia Hospital |
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Name:
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Clare Tempany, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Name:
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Robert Min, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cornell Vascular |
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Name:
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Fred Steinberg, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University MRI |
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Name:
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Mark DeLaurentis, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Virtua |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Fibroadenoma
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Intervention(s)
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Device: ExAblate 2000
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Primary Outcome(s)
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treatment/ablation of breast fibroadenoma
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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