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 | Completed

• 1 other identifier: 16 KHCC 84
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• comparing effectiveness of tattooing versus clipping in SLNBx identification in breast cancer patients in upfront surgery setting, by comparing no. of identified positive or negative intraoperative SLN that were marked with tattooing versus clipping

  To compare the effectiveness of tattooing compared to clipping in SLNBx identification in breast cancer patients in the upfront surgery and neoadjuvant setting, by comparing the number of identified positive or negative intraoperative SLN that were marked with the tattooing technique with the clip technique

  3 years

Secondary Outcomes (3)

• convenience for radiologist to apply clip or tattoo from time and technical perspectives by comparing time spent in applying clip or tattoo and convenience of the application using a questionnaire completed by radiologists after each application

  3 years

• convenience for surgeon to perform SLNBx after lymph node marking from time & technical perspectives by comparing time and ease to identify the marked lymph nodes during surgery using a questionnaire completed by surgeons after each surgery

  3 years

• The convenience for the surgeon to confirm clip or tattoo presence during the SLNBx from time and technical perspectives using a questionnaire completed by surgeons after each surgery

  3 years

Study Arms (2)

Tattoo- Black Eye

EXPERIMENTAL

to mark the biopsied axillary lymph node by tattooing

Device: Tattoo- Black Eye

clip- HydroMARK

ACTIVE COMPARATOR

To mark the biopsied axillary lymph node by clip placement

Device: clip- HydroMARK

Interventions

Tattoo- Black Eye DEVICE

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

Tattoo- Black Eye

clip- HydroMARK DEVICE

Device name: HydroMARK Manufacturer: Biopsy Sciences, LLC

clip- HydroMARK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Diagnosed with breast cancer.
• Scheduled for primary breast surgery with Sentinel Lymph node biopsy (SLNBx) or Axillary Lymph node dissection (ALND).
• Scheduled to undergo pre-operative axillary lymph node biopsy.
• Willing to sign the Informed Consent

You may not qualify if:

• Previous axillary surgeries, SLNBx and/or AD.
• Diagnosed with inflammatory breast cancer.
• Diagnosed with distant metastases.
• Known to have any allergic reaction to any of the investigational products.
• Participating in other studies involving investigational drug(s) (Phases 1-4) within 3 months prior to this study start and/or during study participation.
• Pregnant females or those with a positive pregnancy test result at screening or baseline; breastfeeding females

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, Al 'A̅şimah, 11941, Jordan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr. Mahmoud Al-Masri, MD

  King Hussein Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-center prospective, randomized and quasi double blinded pilot study. The study includes 2 parallel arms

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: May 1, 2023
• Study Start: February 1, 2017
• Primary Completion: November 20, 2019
• Study Completion: August 20, 2020
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)