Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300125
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-02-16
Brief Title:
Percutaneous Cryoablation of Low-risk Early Breast Cancer
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Percutaneous Cryoablation of Low-risk Early Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PRECICE
Brief Summary:
Expand the current evidence base regarding percutaneous cryoablation of early-stage low-risk breast tumors integrated into the standard therapeutic pathway with well-defined follow-up data as well as data on quality of life Demonstrate therefore that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy when necessary The hypothesis is that cryoablation being simple and oncologically effective ensures a better quality of life for the patient reduced morbidity no need for general anesthesia improved cosmetic outcomes and consequently has a lesser psychological impact as well as a better cost-benefit ratio compared to the standard surgical approach
Detailed Description:
PRECICE is a prospective single arm single centre observational study which aims to enroll patients 50 years old diagnosed with early-stage luminal AB unifocal Breast Cancer BC 15 mm in size without in situ component detected at imaging by breast ultrasound Magnetic Resonance Imaging MRI Mammography and confirmed by needle biopsy defining histotype and biology All patients that receive treatment with cryoablation as their standard care for BC followed by RadioTherapy RT according to the MultiDisciplinary Tumor Board MDTB referral and fulfil the inclusion criteria will be prospectively included in the study
Follow-up protocol involved breast imaging with mammography ultrasound and MRI assessment of procedure failure rate quality of life psychological impact oncological outcome and economical efficacy Adjuvant therapy will be planned after further multidisciplinary discussion
Follow-up protocol involved breast imaging with mammography ultrasound and MRI assessment of procedure failure rate quality of life psychological impact oncological outcome and economical efficacy Adjuvant therapy will be planned after further multidisciplinary discussion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None