Feasibility of Preoperative Tattooing of Percutaneously Biopsied Axillary Lymph Node: A Quasi Experimental Pilot Study

NCT03939598 | Unknown

• 1 other identifier: 2018-0345-1105
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates utility of a novel technique using India Ink to aid in the identification and retrieval of axillary lymph nodes during surgery, in breast cancer patients with suspicious lymph nodes. The first part of the study will evaluate the feasibility of the technique in patients who commence their treatment with surgery. Provided its success, the second part of the study will evaluate the applicability of this same technique in patients who receive chemotherapy before having surgery.

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (2)

• Intra-operative identification of tattooed lymph node(s) in upfront surgery group (Phase I)

  In patients undergoing upfront surgery: The rate of successful intraoperative identification of axillary lymph nodes tattooed with black India ink preoperatively.

  December 31, 2019

• Intra-operative identification of tattooed lymph node(s) in the post-neoadjuvant surgery group (Phase II)

  In patients undergoing surgery post-neoadjuvant chemotherapy (and associated lag time): The rate of successful intraoperative identification of axillary lymph nodes tattooed with black India ink preoperatively.

  December 31, 2020

Secondary Outcomes (1)

• Concordance rate between identified sentinel node(s) and tattooed lymph node(s)

  December 31, 2020

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients reporting to Breast Surgery Clinic at Aga Khan University, Main Campus in Karachi, Pakistan

You may qualify if:

• Breast cancer patient (biopsy proven or clinically suspected) with clinically suspicious (palpable on clinical exam or abnormal by ultrasound criteria but not biopsied yet) ipsilateral axillary lymph node(s). The ultrasonographic examination will be considered suspicious for metastasis if one or more of following criteria are present: 1. Eccentric cortical enlargement (\>3 mm) or lobulation with displacement of hilum 2. Absent hilum and irregular border and hypoechoic echotexture 3. Spherical node 4. Perinodal vascularity. (18-20)
• Participants willing to undergo axillary lymph node percutaneous biopsy with marking/tattooing of the biopsied lymph node at AKUH
• Participants intending to have definitive surgery at AKUH

You may not qualify if:

• Participants with terminal disease like renal failure will be excluded because these conditions can have profound effect on their course of treatment
• Participants with distant metastases
• Participants with prior breast or axillary surgery
• Participants with recurrent breast malignancy because their course of treatment might be different
• Participants that were initially suspected to have breast cancer, but pathology results did not confirm the diagnosis
• Pregnant and lactating women
• Men with breast cancer

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (21)

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• Sattar AK, Ali B, Masroor I, Afzal S, Tariq MU, Idrees R, Uzzaman M, Khalid W. Feasibility of preoperative tattooing of percutaneously biopsied axillary lymph node: an experimental pilot study. Pilot Feasibility Stud. 2020 Sep 24;6:140. doi: 10.1186/s40814-020-00682-2. eCollection 2020.

  PMID: 32983557 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Abida K. Sattar, MD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abida K Sattar, MD

CONTACT

+9221 34864751; abida.sattar@aku.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Breast Surgery

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 7, 2019
• Study Start: March 27, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)