MedTrace Logo

Clinical Trial Evaluating the Effectiveness of a Tattoo Compared to a Clip Applied to Axillary Lymph Nodes in Breast Cancer Patients Who Undergo SLNBx

NCT05836337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-05-01

No results posted yet for this study

Summary

This study is a single-center prospective, randomized and quasi double blinded pilot study. The study has 2 parallel arms, each arm involved around 54 patients. Targeted community is the newly diagnosed adults with non metastatic and non inflammatory breast cancer in King Hussein Cancer Center who require axillary biopsy as part of their staging work up. The study aims to improve the intra-operative identification of the preoperatively suspicious and biopsied lymph nodes and test the concordance between the pre-operative clinical suspicion and histopathological results of these node; by comparing between preoperative marking of biopsied axillary lymph nodes with two different modalities (clipping Vs tattooing) and testing its concordance with sentinel lymph node biopsy, both in upfront surgery and neoadjuvant chemotherapy settings and in a prospective, randomized and quasi double blinded design

Conditions

Interventions

DEVICE

Tattoo- Black Eye

Device name: Black eye Manufacturer: The Standard Co., Ltd

DEVICE

clip- HydroMARK

Device name: HydroMARK Manufacturer: Biopsy Sciences, LLC

Sponsors & Collaborators

  • King Hussein Cancer Center

    lead OTHER

Principal Investigators

  • Dr. Mahmoud Al-Masri, MD · King Hussein Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-11-20
Completion
2020-08-20

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05836337 on ClinicalTrials.gov