Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-02-21 @ 12:14 AM
Study NCT ID:
NCT01992250
Status:
UNKNOWN
Last Update Posted:
2018-04-20
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
Sponsor:
Sanarus Technologies, Inc.
Organization:
Study Overview
Official Title:
Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
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:
FROST
Brief Summary:
This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.
Detailed Description:
PURPOSE:
To determine the rate of successful tumor ablation in patients treated with cryoablation and endocrine therapy in a subset of patients with early stage breast cancer.
OUTLINE:
1. Core Biopsy (Pre-Registration)
2. Magnetic Resonance Imaging (Pre-Registration)
3. Tumor Cryoablation
4. Core Biopsy (Post-Cryoablation)
5. Magnetic Resonance Imaging (Post-Cryoablation)
6. Postoperative Follow-up
7. Evaluation of outcomes
To determine the rate of successful tumor ablation in patients treated with cryoablation and endocrine therapy in a subset of patients with early stage breast cancer.
OUTLINE:
1. Core Biopsy (Pre-Registration)
2. Magnetic Resonance Imaging (Pre-Registration)
3. Tumor Cryoablation
4. Core Biopsy (Post-Cryoablation)
5. Magnetic Resonance Imaging (Post-Cryoablation)
6. Postoperative Follow-up
7. Evaluation of outcomes
Study Oversight
Has Oversight DMC:
False
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?: