Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04829643
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2021-03-31
Brief Title:
Axillary Staging in Early Breast Cancer SNB vs PETMRI
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Targeting the Future of Axillary Staging in Early Breast Cancer A Comparative Study Sentinel Node Biopsy vs PETMRI
Status:
RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
The gold standard of surgical treatment for patients with early breast cancer BC is breast conservation and sentinel node biopsy SNB Ongoing randomized trials are evaluating to omit surgery at all when axillary imaging is negative However the available diagnostic tools still have several limitations in accuracy
Combining the specificity of PET with the superior sensitivity of MRI hybrid PETMRI might be a non-invasive one-stage operator-independent imaging method to accurately define nodal status and whenever negative might replace surgery for axillary staging
The project includes patients with 3 cm BC without overt nodal involvement who will undergo PETMRI prior to surgery The primary aim is to compare the staging power between SNB and PETMRI in detecting axillary lymph node macrometastases 2 mm Additionally general concordance and diagnostic accuracy of PETMRI vs SNB eventual correlation with BC molecular subtypes and MRI findings will be evaluated
Combining the specificity of PET with the superior sensitivity of MRI hybrid PETMRI might be a non-invasive one-stage operator-independent imaging method to accurately define nodal status and whenever negative might replace surgery for axillary staging
The project includes patients with 3 cm BC without overt nodal involvement who will undergo PETMRI prior to surgery The primary aim is to compare the staging power between SNB and PETMRI in detecting axillary lymph node macrometastases 2 mm Additionally general concordance and diagnostic accuracy of PETMRI vs SNB eventual correlation with BC molecular subtypes and MRI findings will be evaluated
Detailed Description:
SNB is the gold standard for axillary staging in early BC patients Although being a minimally invasive it is time consuming both for surgeon and pathologist it may add a further scar and is not free from complications seroma limitation of shoulder movement nerve injury lymphedema To date patients undergoing breast conserving surgery BCS with 1 to 2 positive nodes can be treated with SNB alone ACOSOG Z011 trial NCT000038552-4 and researchers are evaluating within large randomized trials to even omit surgery at all when axillary imaging is negative SOUND Sentinel node biopsy vs Observation after axillary Ultra-souND PI and Study Chair DrOGentiliniMD NCT02167490 and INSEMA Intergroup-SEntinel-MAmma trial NCT02466737
While the role of surgery is decreasing the role of preoperative imaging is increasing In the future imaging might even replace surgery in the axillary staging of BC patients still providing an appropriate level of information to guide medical treatments which are more and more tailored on biology rather than on nodal status In this context an unmet need is to achieve the most accurate preoperative imaging assessment of the axilla in order to decide the appropriate treatment for each patient
The hypothesis of this project is that PETMRI might provide a single one-stage non-invasive operator independent imaging modality in patients with small BC allowing to select the proper treatment for patients PETMRI is a relatively new imaging tool and its field of application is still object of scientific speculation
While the role of surgery is decreasing the role of preoperative imaging is increasing In the future imaging might even replace surgery in the axillary staging of BC patients still providing an appropriate level of information to guide medical treatments which are more and more tailored on biology rather than on nodal status In this context an unmet need is to achieve the most accurate preoperative imaging assessment of the axilla in order to decide the appropriate treatment for each patient
The hypothesis of this project is that PETMRI might provide a single one-stage non-invasive operator independent imaging modality in patients with small BC allowing to select the proper treatment for patients PETMRI is a relatively new imaging tool and its field of application is still object of scientific speculation
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