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

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ClinicalTrials.gov Identifier: NCT04829643
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : April 2, 2021
Sponsor:
Collaborator:
IBFM- Consiglio Nazionale delle Ricerche
Information provided by (Responsible Party):
Oreste Davide Gentilini, IRCCS San Raffaele

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 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Sentinel Lymph Node Early-stage Breast Cancer Diagnostic Test: PET/MRI Not Applicable

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 NCT00003855[2-4]) and researchers are evaluating within large randomized trials to even omit surgery at all when axillary imaging is negative (SOUNDSentinel node biopsy vs Observation after axillary Ultra-souND, PI and Study Chair 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 247 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeting the Future of Axillary Staging in Early Breast Cancer: A Comparative Study: Sentinel Node Biopsy vs PET/MRI
Actual Study Start Date : July 3, 2020
Estimated Primary Completion Date : June 16, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PET/MRI
Patients with early breast cancer up to 3 cm without overt nodal involvement who are candidates to upfront surgery
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




Primary Outcome Measures :
  1. SNB vs PET/MRI [ Time Frame: Within one month after surgery results from SNB will be available and compared to preoperative PET/MRI ]
    Results from SNB will be compared to results from PET/MRI


Secondary Outcome Measures :
  1. A secondary outcome is the staging power of PET/MRI compared to preoperative A-US [ Time Frame: At 1 year ]
    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 AUS and those with 1-2 axillary nodes with uncertain US features. These two groups will be analysed independently. The PET/MRI and AUS 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.

  2. Correlation between PET/MRI parameters and breast cancer prognosis [ Time Frame: 0 and 36 mths ]
    Eventual associations between PET/MRI morphological and functional parameters with tumour prognostic features will be investigated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed Informed Consent
  • age > 18
  • cT < 3 cm
  • non palpable lymph nodes
  • no suspicious nodes at A-US
  • candidate to mastectomy or breast conserving surgery and BLS

Exclusion Criteria:

  • pregnancy
  • distant metastasis
  • inflamatory cancer
  • claustrophobia
  • allergy to contrast agent
  • severe renal insufficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829643


Contacts
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Contact: ORESTE D GENTILINI, MD +39 2643.3939 gentilini.oreste@hsr.it
Contact: ROSA DI MICCO, MD dimicco.rosa@hsr.it

Locations
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Italy
Oreste Davide Gentilini Recruiting
Milano, MI, Italy, 20132
Contact: ORESTE D GENTILINI    0039.2643.3939    gentilini.oreste@hsr.it   
Contact: ROSA DI MICCO       dimicco.rosa@hsr.it   
Sub-Investigator: ROSA DI MICCO         
Sub-Investigator: CARLA CANEVARI         
Sub-Investigator: PIETRO PANIZZA, Co-PI         
Sub-Investigator: ELENA VENTURINI         
Sponsors and Collaborators
IRCCS San Raffaele
IBFM- Consiglio Nazionale delle Ricerche
Investigators
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Principal Investigator: ORESTE D GENTILINI, MD Director Breast Unit
Publications:

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Responsible Party: Oreste Davide Gentilini, Head of Breast Unit, Head of Breast Surgery, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04829643    
Other Study ID Numbers: SNBvsPET/MRI 2
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oreste Davide Gentilini, IRCCS San Raffaele:
PET/MRI
sentinel node biopsy
early breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases