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Feasibility of Preoperative Tattooing of Percutaneously Biopsied Axillary Lymph Node: A Quasi Experimental Pilot Study
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.
| Condition or disease |
|---|
| Breast Neoplasm |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 40 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Feasibility of Preoperative Tattooing of Percutaneously Biopsied Axillary Lymph Node: A Quasi Experimental Pilot Study |
| Actual Study Start Date : | March 27, 2019 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | December 31, 2020 |
- Intra-operative identification of tattooed lymph node(s) in upfront surgery group (Phase I) [ Time Frame: December 31, 2019 ]In patients undergoing upfront surgery: The rate of successful intraoperative identification of axillary lymph nodes tattooed with black India ink preoperatively.
- Intra-operative identification of tattooed lymph node(s) in the post-neoadjuvant surgery group (Phase II) [ Time Frame: December 31, 2020 ]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.
- Concordance rate between identified sentinel node(s) and tattooed lymph node(s) [ Time Frame: December 31, 2020 ]The rate of concordance between the intra-operatively identified sentinel node and tattooed node(s)
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 bilateral breast cancer, and those who have already had an axillary core needle biopsy prior to inclusion (to avoid a second procedure for tattooing)
- 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
| Contact: Abida K Sattar, MD | +9221 34864751 | abida.sattar@aku.edu |
| Pakistan | |
| Aga Khan University | Recruiting |
| Karachi, Sindh, Pakistan, 74800 | |
| Contact: Dr Abida K Sattar, MD 021-34864751 abida.sattar@aku.edu | |
| Principal Investigator: | Abida K. Sattar, MD | The Aga Khan University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 24, 2019 | ||||
| First Posted Date | May 7, 2019 | ||||
| Last Update Posted Date | May 7, 2019 | ||||
| Actual Study Start Date | March 27, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Concordance rate between identified sentinel node(s) and tattooed lymph node(s) [ Time Frame: December 31, 2020 ] The rate of concordance between the intra-operatively identified sentinel node and tattooed node(s)
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Feasibility of Preoperative Tattooing of Percutaneously Biopsied Axillary Lymph Node: A Quasi Experimental Pilot Study | ||||
| Official Title | Feasibility of Preoperative Tattooing of Percutaneously Biopsied Axillary Lymph Node: A Quasi Experimental Pilot Study | ||||
| 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. |
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| Detailed Description |
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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients reporting to Breast Surgery Clinic at Aga Khan University, Main Campus in Karachi, Pakistan | ||||
| Condition | Breast Neoplasm | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
40 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2020 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Pakistan | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03939598 | ||||
| Other Study ID Numbers | 2018-0345-1105 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Abida K. Sattar, MD, FACS, Aga Khan University | ||||
| Study Sponsor | Aga Khan University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Aga Khan University | ||||
| Verification Date | May 2019 | ||||
