Status:
COMPLETED
Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI
Lead Sponsor:
IRCCS San Raffaele
Collaborating Sponsors:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Conditions:
Breast Cancer Female
Node-positive Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The management of axillary nodes in breast cancer patients is a highly debated and evolving field. To date, an increasing number of patients with positive lymph nodes receives primary systemic therapy...
Detailed Description
HYPOTHESIS: Hybrid PET/MRI might be a non-invasive, one-stage, operator-independent imaging modality to accurately define nodal status after PST, properly select type of surgical approach and might ev...
Eligibility Criteria
Inclusion
- Signed informed consent;
- Age \> 18 years;
- Proven diagnosis of early BC of any size;
- Patients candidate to primary systemic therapy (PST);
- Positive axillary nodes at diagnosis, confirmed by either citology or histology confirmation. Patients with clear overt clinical and radiological nodal involvement might be enrolled as well without FNA or microhystology
Exclusion
- inflammatory BC;
- pregnancy;
- contraindication to PET;
- distant metastases;
- no surgery after PST;
- contraindication to MRI;
- claustrophobia;
- allergy to the MR contrast agent;
- severe renal insufficiency.
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04826211
Start Date
November 4 2019
End Date
December 31 2024
Last Update
August 1 2025
Active Locations (1)
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1
Ospedale San Raffaele
Milan, MI, Italy, 20132