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Axillary Staging in Node Positive Breast Cancer Patients Receiving PST. SNB vs PET/MRI

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ClinicalTrials.gov Identifier: NCT04826211
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
IBFM- Consiglio Nazionale delle Ricerche
Information provided by (Responsible Party):
Oreste Davide Gentilini, IRCCS San Raffaele

Study Description
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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 (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.


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

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 eventually lead to the omission of axillar surgery in some breast cancer patients showing complete imaging response.

AIMS: The primary endpoint is to compare the staging power between SNB (or lymphoadenectomy) vs PET/MRI in detecting axillary lymph node macro-metastases (>2 mm).Additionally the PET/MRI and A-US results will be confronted and ultimately related to pathology result, calculating the concordance rate in terms of positive vs 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.

EXPERIMENTAL DESIGN: Patients with breast cancer of any size with positive axillary nodes and candidates to PST will undergo PET/MRI prior to PST.

The study population will then be split into two groups:

  • women with positive axillary lymph nodes after PST (Group 1, 60% of the total)
  • women with negative axillary lymph nodes after PST (Group 2, 40% of the total).

A total of 110 women will guarantee two well-powered independent analysis. one for Group 1 (n=66; power>90%; Type I error rate of 0.05) and one for Group 2 (n=44; power>80%; Type I error rate of 0.05).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 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 Node Positive Breast Cancer Patients Receiving Primary Systemic Therapy. A Comparative Study Between Sentinel Node Biopsy vs PET/MRI.
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Node positive BC patients undergoing PST
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
 Diagnostic Test: PET/MRI
All included patients will undergo PET/MRI both prior to PST and prior to surgery. In order to analyze results the population will be divided into two groups: women with positive axillary lymph nodes after PST (Group 1) and women with negative axillary lymph nodes after PST (Group 2).


Outcome Measures
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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 (or axillary dissection) will be compared to results from PET/MRI.

    In detail, results from PET/MRI on axillary nodes will be scored as: positive, suspicious, doubtful or negative. For the purpose of the study, suspicious and positive axillary nodes will be considered as positive (metastatic),whilst negative and doubtful axillary nodes will be considered negative (healthy). These results will be compared with final pathology, where lymph nodes containing a metastasis larger than 2 mm will be defined as positive.

    The concordance between PET/MRI and pathological results will be defined as present when both methods agree in defining axillary nodes as positive or negative, when the two methods disagree the concordance will be absent.

    The concordance rate will be calculated as the percentage of concordant results on the total patients.



Secondary Outcome Measures :
  1. Axillary US vs PET/MRI [ Time Frame: At 1 year ]

    Results from axillary US will be compared to results from PET/MRI. In detail results from both Axillary US and PET/MRI will be classified as positive, suspicious, doubtful and negative. For the purpose of the study, positive and suspicious results will be considered positive whilst negative and doubtful results will be considered negative.

    The concordance rate between the two methods will be calculated as the percentage of concordant results on the total patients.


  2. Correlation between PET/MRI parameters and prognosis [ Time Frame: At baseline and at 5 years ]

    Quantitative analysis of PET/MRI exams will allow to extract standard imaging biomarkers to be correlated with tumour clinical and pathological data. Image analysis will be carried out both at staging and at the end of PST.

    Functional parameters from PET image analysis include Standardized Uptake Value and Metabolic Tumor Volume.

    From breast MR images, the quantitative and semiquantitative data are related to DWI and DCE MR sequences. Specifically, from the so-called Time Intensity Curve (TIC) obtained from the dynamic DCE some parameters can be extracted, for example Time To Peak, Peak Enhancement Percentage, Signal Enhancement Ratio and Initial Enhancement Percentage. From DWI MR sequence Apparent Diffusion Coefficient map can be calculated.



Eligibility Criteria
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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 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.
Contacts and Locations
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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): NCT04826211


Contacts
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Contact: ORESTE DAVIDE GENTILINI, PI 02-26433939 gentilini.oreste@hsr.it
Contact: ROSA DI MICCO, SI dimicco.rosa@hsr.it

Locations
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Italy
Ospedale San Raffaele Recruiting
Milano, MI, Italy, 20132
Contact: ORESTE DAVIDE GENTILINI       gentilini.oreste@hsr.it   
Sub-Investigator: ROSA DI MICCO         
Sub-Investigator: LUIGI GIANOLLI         
Sub-Investigator: CARLA CANEVARI         
Sub-Investigator: PIETRO PANIZZA         
Sub-Investigator: CLAUDIO LOSIO         
Sub-Investigator: ELENA VENTURINI         
Sub-Investigator: ZUBER VERONICA         
Sub-Investigator: ANNARITA SAVI         
Sponsors and Collaborators
Oreste Davide Gentilini
IBFM- Consiglio Nazionale delle Ricerche
Investigators
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Principal Investigator: GENTILINI IRCCS San Raffaele
More Information
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Publications:

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Responsible Party: Oreste Davide Gentilini, Head of Breast Surgery, Head of Breast Unit, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04826211    
Other Study ID Numbers: SNB vs PET/MRI 1
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
primary systemic therapy
node positive breast cancer
surgery after primary systemic therapy
PET/MRI
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases