Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT00723294
Status:
UNKNOWN
Last Update Posted:
2017-08-14
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cryoablation Therapy in Treating Patients With Invasive Ductal Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.
Detailed Description:
This is a phase II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. Patients will then undergo complete surgical resection of the primary tumor. The primary and secondary objectives of the study are described below.
OBJECTIVES:
Primary
* To determine the rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion
Secondary
* To evaluate the negative predictive value of MRI in the post-ablation setting to determine residual in situ or invasive breast carcinoma
* To describe the adverse events associated with cryoablation
* To prospectively gather pain assessment data on cryoablation and surgical resection
* Explore technical variables that may affect the success of cryoablation
OBJECTIVES:
Primary
* To determine the rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion
Secondary
* To evaluate the negative predictive value of MRI in the post-ablation setting to determine residual in situ or invasive breast carcinoma
* To describe the adverse events associated with cryoablation
* To prospectively gather pain assessment data on cryoablation and surgical resection
* Explore technical variables that may affect the success of cryoablation
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000600976 | None | None | View |