Axillary Staging in Early Breast Cancer: SNB vs PET/MRI

Breast Cancer Clinical Trial

Official title:

Targeting the Future of Axillary Staging in Early Breast Cancer: A Comparative Study: Sentinel Node Biopsy vs PET/MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829643
• Other study ID #: SNBvsPET/MRI 2
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: February 14, 2025

Study information

• Verified date: September 2023
• Source: IRCCS San Raffaele
• Contact: ORESTE D GENTILINI, MD
• Phone: +39 2643.3939
• Email: gentilini.oreste[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 PET/MRI 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 PET/MRI prior to surgery. The primary aim is to compare the staging power between SNB and PET/MRI in detecting axillary lymph node macrometastases (>2 mm). Additionally, general concordance and diagnostic accuracy of PET/MRI vs SNB, eventual correlation with BC molecular subtypes and MRI findings will be evaluated.

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 NCT00003855[2-4]) 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 Dr.O.Gentilini,MD, 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 PET/MRI 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. PET/MRI is a relatively new imaging tool and its field of application is still object of scientific speculation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 247
• Est. completion date: February 14, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• signed Informed Consent

• age > 18

• cT < 3 cm

• non palpable lymph nodes

• no suspicious nodes at A-US (Axillary- ultrasound)

• candidate to mastectomy or breast conserving surgery and BLS (Sentinel Node Biopsy)

Exclusion Criteria:

• pregnancy

• distant metastasis

• inflammatory cancer

• claustrophobia

• allergy to contrast agent

• severe renal insufficiency

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Early-stage Breast Cancer
• Sentinel Lymph Node

Intervention

Diagnostic Test:
• PET/MRI
A consecutive cohort of 247 patients with early BC and no suspicious nodes at both clinical and A-US evaluations and candidates to upfront surgery and SNB will be recruited

Locations

Country	Name	City	State
Italy	Oreste Davide Gentilini	Milano	MI

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	IBFM- Consiglio Nazionale delle Ricerche

Country where clinical trial is conducted

Italy, 

References & Publications (8)

Gentilini 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. — View Citation

Heusch 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. — View Citation

Melsaether 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. — View Citation

Pilewskie M, Jochelson M, Gooch JC, Patil S, Stempel M, Morrow M. Is Preoperative Axillary Imaging Beneficial in Identifying Clinically Node-Negative Patients Requiring Axillary Lymph Node Dissection? J Am Coll Surg. 2016 Feb;222(2):138-45. doi: 10.1016/j.jamcollsurg.2015.11.013. Epub 2015 Nov 25. — View Citation

Stadnik TW, Everaert H, Makkat S, Sacre R, Lamote J, Bourgain C. Breast imaging. Preoperative breast cancer staging: comparison of USPIO-enhanced MR imaging and 18F-fluorodeoxyglucose (FDC) positron emission tomography (PET) imaging for axillary lymph node staging--initial findings. Eur Radiol. 2006 Oct;16(10):2153-60. doi: 10.1007/s00330-006-0276-4. Epub 2006 May 3. — View Citation

Taneja S, Jena A, Goel R, Sarin R, Kaul S. Simultaneous whole-body (1)(8)F-FDG PET-MRI in primary staging of breast cancer: a pilot study. Eur J Radiol. 2014 Dec;83(12):2231-2239. doi: 10.1016/j.ejrad.2014.09.008. Epub 2014 Sep 28. — View Citation

van 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. — View Citation

Veronesi 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNB vs PET/MRI	Results from SNB will be compared to results from PET/MRI y results from SNB will be available and compared to results of preoperative PET/MRI	Within 1 month after surgery
Secondary	A secondary outcome is the staging power of PET/MRI compared to preoperative A-US (Axillary Ultrasound)	Study will focus on a subgroup of patients having one or two uncertain but no suspicious axillary nodes for which SNB is still indicated. Patient population will be divided into two cohorts: those with completely normal axillary lymph node at A-US and those with 1-2 axillary nodes with uncertain ultrasound features. These two groups will be analysed independently. The PET/MRI and A-US results will be compared to each other and ultimately to final pathology, calculating the concordance rate in terms of positive versus negative nodes and number of positive nodes detected by each method. The staging power of both preoperative exams will be evaluated by considering how many times the results from PET/MRI or A-US could have indicated the most appropriate axillary treatment according to pathological findings.	At 12 months
Secondary	Correlation between PET/MRI parameters and breast cancer prognosis	Eventual associations between PET/MRI morphological and functional parameters with tumour prognostic features will be investigated.	0 and 36 months