Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-28 @ 4:17 AM
Study NCT ID:
NCT06738459
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
Study Overview
Official Title:
Precision Retrospective Integrative Study for Metastatic Lymph Nodes in Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-12
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:
PRISM
Brief Summary:
Accurate assessment of axillary lymph nodes in patients with breast cancer is essential for prognosis and treatment planning. Staging and surgical management have evolved from axillary lymph node dissection to sentinel lymph node biopsy to minimize morbidity. However, sentinel lymph node biopsy has non-negligible morbidity, and more than 70% of biopsies are negative, calling into question its routine use. Magnetic resonance imaging (MRI) can be used to detect and stage lymph node metastases in situ, but its sensitivity and specificity are moderate to poor. Few studies have employed artificial intelligence to detect lymph node metastases on MRI images, and none have used an integrative multidata approach (IMA), defined as modeling the combination of clinical and laboratory data with multiparametric MRI.
The primary objective of this retrospective observational study is to improve the accuracy of detecting lymph node involvement in breast cancer using IMA. The secondary objective is to allow longitudinal monitoring of the effects of neoadjuvant therapy on lymph node involvement
The primary objective of this retrospective observational study is to improve the accuracy of detecting lymph node involvement in breast cancer using IMA. The secondary objective is to allow longitudinal monitoring of the effects of neoadjuvant therapy on lymph node involvement
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: