Clinical trial · Interventional
Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI
Targeting the Future of Axillary Staging in Node Positive Breast Cancer Patients Receiving Primary Systemic Therapy. A Comparative Study Between Sentinel Node Biopsy vs PET/MRI.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 (PST) prior to surgery leading to down-staging axillary nodes in about 40% of women. However, the available diagnostic methods have several limitations in properly evaluating the response after treatment both in the breast and in the nodes and might lead to either under or over-treatment in these patients. Fully integrated scanners capable of simultaneous acquisition of PET and MRI have now been developed, with the potential to combine the specificity obtained by the functional imaging of PET, with the superior sensitivity of MRI, to provide higher diagnostic accuracy. It is expected that PET/MRI could better determine the response after PST to distinguish patients with negative versus patients with positive axillary nodes after medical treatment. As the excision of axillary nodes has mainly a staging purpose, the reliable identification of node negative patients might eventually spare women from unnecessary surgery. An accurate over-time and final imaging work-up might help choose the appropriate type of surgery according to the extent of nodal involvement: either SNB or complete axillary clearance.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Node-positive Breast Cancer | — | UNRESOLVED | — |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Node positive BC patients undergoing PST
- description
- Patients with breast cancer of any size with positive axillary nodes and candidates to PST will undergo PET/MRI both prior to PST and after PST before surgery
- interventionNames
- Diagnostic Test: PET/MRI
Primary outcomes (1)
- measure
- Axillary surgery vs PET/MRI.
- timeFrame
- Within 1 month after surgery results from axillary surgery will be available and compared to preoperative PET/MRI
- description
- Results from SNB (Sentinel Node Biopsy), AD (Axillary Dissection) or any axillary surgery will be compared to results from preoperative PET/MRI.
Secondary outcomes (2)
- measure
- Staging power of PET/MRI will be compared to preoperative A-US (Axillary ultrasound)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (9)
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- BACKGROUNDMelsaether AN, Raad RA, Pujara AC, Ponzo FD, Pysarenko KM, Jhaveri K, Babb JS, Sigmund EE, Kim SG, Moy LA. Comparison of Whole-Body (18)F FDG PET/MR Imaging and Whole-Body (18)F FDG PET/CT in Terms of Lesion Detection and Radiation Dose in Patients with Breast Cancer. Radiology. 2016 Oct;281(1):193-202. doi: 10.1148/radiol.2016151155. Epub 2016 Mar 29. PMID 27023002
- BACKGROUNDVeronesi U, De Cicco C, Galimberti VE, Fernandez JR, Rotmensz N, Viale G, Spano G, Luini A, Intra M, Veronesi P, Berrettini A, Paganelli G. A comparative study on the value of FDG-PET and sentinel node biopsy to identify occult axillary metastases. Ann Oncol. 2007 Mar;18(3):473-8. doi: 10.1093/annonc/mdl425. Epub 2006 Dec 12. PMID 17164229
- BACKGROUNDGentilini O, Veronesi U. Staging the Axilla in Early Breast Cancer: Will Imaging Replace Surgery? JAMA Oncol. 2015 Nov;1(8):1031-2. doi: 10.1001/jamaoncol.2015.2337. No abstract available. PMID 26291922
- BACKGROUNDvan Nijnatten TJA, Goorts B, Voo S, de Boer M, Kooreman LFS, Heuts EM, Wildberger JE, Mottaghy FM, Lobbes MBI, Smidt ML. Added value of dedicated axillary hybrid 18F-FDG PET/MRI for improved axillary nodal staging in clinically node-positive breast cancer patients: a feasibility study. Eur J Nucl Med Mol Imaging. 2018 Feb;45(2):179-186. doi: 10.1007/s00259-017-3823-0. Epub 2017 Sep 14. PMID 28905091
- BACKGROUNDHeusch P, Nensa F, Schaarschmidt B, Sivanesapillai R, Beiderwellen K, Gomez B, Kohler J, Reis H, Ruhlmann V, Buchbender C. Diagnostic accuracy of whole-body PET/MRI and whole-body PET/CT for TNM staging in oncology. Eur J Nucl Med Mol Imaging. 2015 Jan;42(1):42-8. doi: 10.1007/s00259-014-2885-5. Epub 2014 Aug 12.