Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147108
Status:
TERMINATED
Last Update Posted:
2012-09-17
First Post:
2005-09-02
Brief Title:
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Sponsor:
InSightec
Organization:
InSightec
Study Overview
Official Title:
Phase 3 Study of MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ovalelliptical lump in the breast These patients then go on to receive mammograms sonograms and usually a core biopsy for the differential diagnosis of benign disease fibroadenoma vs breast cancer Although fibroadenomas are benign they can be of great concern to the patient because of their ability to mask the presence of other lumps in the breast they can be painful cause a physical deformity of the breast or have other symptoms The current treatment is surgical excision Surgical removal is invasive and may be cosmetically undesirable to some patients It would be advantageous to develop a non-invasive ablative method for treatment of this disease Measures of the clinical success of patients who elect surgical removal of fibroadenomas are generally subjective and evaluated primarily by the patient lack of palpable lesion pain free and an acceptable cosmetic result A non-randomized study is proposed to allow for a more practical approach in subject recruitment Analysis on safety and efficacy will be performed through the use of MRI evaluation and physical exams
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None