An observational study in Breast Neoplasm, sponsored by Aga Khan University. Status unknown at 1 site in Pakistan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by Aga Khan University · Observational
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.
Breast cancer is the leading cause of cancer mortality among females. Sentinel lymph node biopsy helps avoid axillary lymph node dissection and the associated morbidity. However, its utility is unclear in patients with biopsy proven axillary disease that has been treated with neoadjuvant chemotherapy. The objective of our study is to evaluate a) the feasibility of a novel technique of preoperatively tattooing suspicious lymph nodes with India ink, their intraoperative identification and retrieval in patients undergoing upfront breast and axillary surgery(Phase I); and b) the application of this technique in patients who undergo surgery after receiving neo-adjuvant chemotherapy i.e. lag time between tattooing and lymph node retrieval (Phase II) with the ultimate objective to see if the status of the excised sentinel and tattooed lymph node will be predictive of the status of the axilla.
A quasi-experimental pilot study will be conducted to evaluate the feasibility of tattooing suspicious lymph nodes with sterile black India ink. The study will be conducted in two phases, with the second phase conditional upon the successful results of the first. In Phase I, only 10 patients who are committed to undergo upfront surgery (without neoadjuvant chemotherapy) will be included. These patients will have the suspicious lymph node tattooed by injecting India ink at the time of ultrasound guided core needle biopsy. Intraoperatively, the axilla will be inspected to determine whether India ink tattooed in the lymph nodes can be visualized by the surgeon. Microscopic inspection for the presence of the dye in nodes retrieved by sentinel biopsy and/or axillary dissection will also be done. In Phase II, this process will be repeated for patients who undergo surgery after neoadjuvant chemotherapy and concordance between the sentinel, tattooed and non-sentinel nodes will be determined.
Ethical approval was obtained from the Aga Khan University Ethical Review Board (ERC# 2018-0345-1105). The process of sentinel node biopsy is a safe and routinely performed procedure at our institution. Intradermal injection of methylene blue can lead to skin necrosis; intra-parenchymal injection can cause induration and erythema with associated pain. These side effects can be minimized by diluting methylene blue which will be done. The complications that can result from all additional steps of study procedures will be discussed with the patient and their full responsibility will be borne by the institution. Although sterile black India Ink is safe to administer but possible side effects can include mucosal inflammation due to spillage of the ink, abscess formation and others such as an allergic reaction. If any of these situations are encountered full responsibility to treat the side effects will be borne by the study team using departmental funds.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 40 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Aga Khan University is the lead sponsor of 293 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients reporting to Breast Surgery Clinic at Aga Khan University, Main Campus in Karachi, Pakistan
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Exclusion Criteria:
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.
Time frame: 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.
Time frame: December 31, 2020
Concordance rate between identified sentinel node(s) and tattooed lymph node(s)
The rate of concordance between the intra-operatively identified sentinel node and tattooed node(s)
Time frame: December 31, 2020
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Mar 2019 (actual). Primary completion is estimated for Dec 2019, 9 months after the start.
Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's planned 9 months is below that.
Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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