Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008437
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2001-01-06
Brief Title:
MRI-Guided Ultrasound Energy in Treating Patients With Stage I Stage II or Stage IIIA Breast Cancer
Sponsor:
InSightec
Organization:
InSightec
Study Overview
Official Title:
Pilot Study of MR-Guided Focused Ultrasound for Tissue Coagulation in Women With Breast Cancer MR Imaging and Histopathic Correlation An Assessment or Target Accuracy and Patient Acceptance
Status:
COMPLETED
Status Verified Date:
2012-06
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:
RATIONALE Imaging procedures such as MRI may allow the doctor to better detect the tumor Highly focused ultrasound energy may be able to kill tumor cells by heating the breast tumor cells without affecting the surrounding tissue
PURPOSE Phase II trial to study the effectiveness of MRI-guided ultrasound energy in treating women who have stage I stage II or stage IIIA breast cancer
PURPOSE Phase II trial to study the effectiveness of MRI-guided ultrasound energy in treating women who have stage I stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES
Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer
Determine the ability to accurately and thoroughly coagulate a target volume of breast carcinoma in terms of real-time target volume temperature profile follow-up MRI and histology using this procedure
Compare the appearance of gross and microscopic histopathologic tissue post coagulation with the pre- and post-coagulation magnetic resonance appearance of the targeted volume and measure any residual cancer cells in patients after this procedure
Determine patient acceptance of this procedure in terms of positioning pain safety and follow-up cosmesis
OUTLINE This is a pilot study
Patients undergo MRI-guided focused ultrasound MRgFUS ablation of the breast lesion using a series of pulses Within 72 hours after MRgFUS procedure patients undergo gadolinium-enhanced MRI to evaluate ablation borders Within 7-10 days after MRgFUS procedure patients undergo an ultrasound exam Guide wires may be placed to assist in pre-surgical lesion localization Within 10-21 days after MRgFUS procedure patients undergo segmental resection or mastectomy
Patients are followed at 5-10 days post-surgery
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
Determine the incidence and severity of adverse events during and after MRI-guided focused ultrasound ablation in women with stage I-IIIA breast cancer
Determine the ability to accurately and thoroughly coagulate a target volume of breast carcinoma in terms of real-time target volume temperature profile follow-up MRI and histology using this procedure
Compare the appearance of gross and microscopic histopathologic tissue post coagulation with the pre- and post-coagulation magnetic resonance appearance of the targeted volume and measure any residual cancer cells in patients after this procedure
Determine patient acceptance of this procedure in terms of positioning pain safety and follow-up cosmesis
OUTLINE This is a pilot study
Patients undergo MRI-guided focused ultrasound MRgFUS ablation of the breast lesion using a series of pulses Within 72 hours after MRgFUS procedure patients undergo gadolinium-enhanced MRI to evaluate ablation borders Within 7-10 days after MRgFUS procedure patients undergo an ultrasound exam Guide wires may be placed to assist in pre-surgical lesion localization Within 10-21 days after MRgFUS procedure patients undergo segmental resection or mastectomy
Patients are followed at 5-10 days post-surgery
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1643 | None | None | None |
| TXS-G990184 | None | None | None |
| DFCI-99029 | None | None | None |
| MDA-ID-99137 | None | None | None |
| TXS-1999-P-00992510 | None | None | None |