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Preoperative and Intraoperative Quantification of Axillary Tumoral Load

Sponsor
Parc de Salut Mar (Other)
Overall Status
Terminated
CT.gov ID
NCT02197949
Collaborator
(none)
12
Enrollment
1
Location
20
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

At present, patients diagnosed of a breast cancer with infiltration of the axillary lymph-nodes are submitted to axillary lymph-node dissection (ALND). The sentinel node (SN) technique is not indicated when a lymph-node biopsy or cytology is positive, nor when the surgical treatment is upfront neither when a neoadjuvant systemic therapy is indicated. The reason for not performing SN is that patients diagnosed of an infiltrated axilla though ultrasound-guided biopsy or cytology tend to have a higher tumoral load than those diagnosed after a sentinel biopsy. Furthermore, even if these patients are submitted to a neoadjuvant systemic treatment and the axillary clinical exploration is negative after the treatment, different studies showed that the SN false negative rate is unacceptably high.

Despite these facts, a high proportion of patients with a positive axilla at diagnosis and submitted to level I and II axillary lymph node dissection show few lymph nodes infiltrated in the pathological study, frequently four or less neoplastic nodes. New methods of detecting these patients with limited infiltrated nodes should be developed and new approaches to axillary surgery (i.e., partial resection) should be offered.

To date, the only information expected to get after an axillary imaging is performed is if the axilla is infiltrated or not. No information about the tumoral load is demanded. In the other hand, level I and II ALND is performed according to established anatomic limits, without selecting the nodes to be excised neither identifying the ones infiltrated for a directed excision.

The aim of the study is to evaluate the ability of a specified and reproducible imaging protocol for distinguishing patients with a high axillary tumoral load from the ones with a low tumoral load. At the same time, as the initial nodes receiving lymph drainage should be the ones commonly affected, identifying these nodes injecting diluted methylene blue in the retroareolar parenchyma and studying their tumoral load could help selecting patients with high from those with low axillary tumoral load.

Evaluation of both steps (that is, first the imaging protocol followed by the methylene blue protocol), could eventually help to distinguish which patients should be submitted to a classical level I and II ALND and which ones can be spared from excising the lymph nodes not stained by the methylene blue.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    12 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Preoperative and Intraoperative Quantification of Axillary Tumoral Load to Reduce the Need of Axillary Lymph Node Dissection in Breast Cancer Patients With Positive Lymph-nodes at Diagnosis
    Study Start Date :
    Jul 1, 2014
    Actual Primary Completion Date :
    Mar 1, 2016
    Actual Study Completion Date :
    Mar 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Breast cancer patients with infiltrated axillary l

    Outcome Measures

    Primary Outcome Measures

    1. Axillary tumoral load [During surgery (one evaluation)]

      -Accuracy to detect patients with low axillary tumoral load (in terms of sensibility and specificity) of a protocol including systematic a reproducible axillary imaging and identification of the first axillary nodes through methylene blue retroareolar injection.

    Secondary Outcome Measures

    1. Methylene blue injection to identify nodes of the lymphatic drainage. [During surgery (one evaluation)]

      -Identification of clinical data influencing accuracy of methylene blue injection to identify the first four to six lymph nodes of the lymphatic drainage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Breast cancer patients with infiltrated axillary lymph nodes cT1-4 cN1

    • Older than 18 years old

    • Able to understand and accept the protocol procedure and to sign an informed consent form in accordance with national legislation.

    Exclusion Criteria:

    • Breast cancer patients in whom no information about axillary lymph nodes status (cytology or biopsy) is available.

    • Patients younger than 18 years old.

    • Psychiatric disease

    • Difficulties to understand Spanish.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital del Mar Barcelona Spain 08003

    Sponsors and Collaborators

    • Parc de Salut Mar

    Investigators

    • Principal Investigator: Maria del Mar Vernet, MD, PhD, Parc de Salut Mar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria del Mar Vernet, MD, Parc de Salut Mar
    ClinicalTrials.gov Identifier:
    NCT02197949
    Other Study ID Numbers:
    • ELISA
    First Posted:
    Jul 23, 2014
    Last Update Posted:
    Nov 8, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Nov 8, 2016