Preoperative and Intraoperative Quantification of Axillary Tumoral Load

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT02197949
First received: July 18, 2014
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Axillary tumoral load [ Time Frame: During surgery (one evaluation) ] [ Designated as safety issue: No ]
    -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:
  • Methylene blue injection to identify nodes of the lymphatic drainage. [ Time Frame: During surgery (one evaluation) ] [ Designated as safety issue: No ]
    -Identification of clinical data influencing accuracy of methylene blue injection to identify the first four to six lymph nodes of the lymphatic drainage.


Estimated Enrollment: 120
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer patients with infiltrated axillary l

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02197949

Contacts
Contact: Maria del Mar Vernet-Tomas, MD, PhD +34932483129 mvernet@hospitaldelmar.cat

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Maria Vernet-Tomas, PhD    +34932483129    mvernet@hospitaldelmar.cat   
Principal Investigator: Maria del Mar Vernet-Tomas, MD, PhD         
Sub-Investigator: Josep Maria Corominas, MD, PhD         
Sponsors and Collaborators
Parc de Salut Mar
Investigators
Principal Investigator: Maria del Mar Vernet, MD, PhD Parc de Salut Mar
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02197949     History of Changes
Other Study ID Numbers: ELISA
Study First Received: July 18, 2014
Last Updated: July 22, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014