World Journal of Surgery

, Volume 42, Issue 5, pp 1391–1395 | Cite as

Prospective Randomized Trial of Use of In-House Prepared Low-Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer

  • Gaurav Agarwal
  • Sendhil Rajan
  • Sabaretnam Mayilvaganan
  • Anjali Mishra
  • Narendra Krishnani
  • Sanjay Gambhir
Original Scientific Report



The current standard-of-care for surgical staging of the axilla in clinically node-negative (N0) early breast cancers is sentinel lymph node biopsy (SLNB), which requires expensive radiopharmaceuticals for efficacious results. In-house produced low-cost radiopharmaceuticals may be the solution and have shown efficacy in earlier observational/pilot studies. We compared SLNB using in-house prepared radiopharmaceutical (99mTc-Antimony-colloid) versus commercially marketed radiopharmaceutical (99mTc-Sulphur-colloid) in this prospective randomized study.

Study Design

78 clinically N0 early breast cancer patients (T1/2, N0 stages), undergoing primary surgery were prospectively randomized 1:1 into two groups; to receive SLNB using methylene blue, and either 99mTc-Antimony colloid (Group-1) or  99mTc-Sulphur colloid (Group-2). Completion axillary dissection was done in all (validation SLNB). SLNB indices were compared between the groups.


The groups were comparable with regard to age, stage, tumour size, hormone receptors and HER2neu status. Cost of the in-house prepared 99mTc-antimony colloid was 16-times lesser compared to 99mTc-sulphur colloid. SLN identification rates (IR) in Groups 1 and 2 were 100 and 97.4% respectively, (p > 0.05). False negative rates (FNR) in Group 1 and 2 were 6.3% (1/16 patients) and 7.7% (1/13 patients), respectively, (p > 0.05). There were no major allergic reactions in either group.


In this prospective randomized trial on early breast cancer patients, accuracy of SLNB was comparable using in-house prepared, 99mTc-antimony colloid and commercially marketed 99mTc-sulphur colloid as radiopharmaceutical, while 99mTc-antimony colloid was much cheaper than 99mTc-sulphur colloid.



This prospective study was made possible with the aid of a SGPGIMS Intramural Grant. The authors would also like to acknowledge the Resident Surgeons of the Department of Endocrine and Breast Surgery, SGPGIMS, Lucknow; and Mr. Subhash Kheruka of the Department of Nuclear Medicine, SGPGIMS, Lucknow for their help.

Compliance with ethical standards

Conflict of interest



  1. 1.
    Mansel RE, Fallowfield L, Kissin M et al (2006) Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. J Natl Cancer Inst 98(9):599–609CrossRefPubMedGoogle Scholar
  2. 2.
    Krag DN, Anderson SJ, Julian TB et al (2007) Technical outcomes of sentinel-lymph node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial. Lancet Oncol 8:881–888CrossRefPubMedGoogle Scholar
  3. 3.
    Shah SQ (2006) New technology of technetium-99 labeled antimony trisulfide colloid intended for sentinel lymph node imaging. Pharm Chem J 40:151CrossRefGoogle Scholar
  4. 4.
    Smyth DR (2006) Rapid determination of the radiochemical purity of 99mTc-antimony trisulfide colloid prepared by standard and alternative heating methods. J Nucl Med Technol. 34(3):174–178PubMedGoogle Scholar
  5. 5.
    Fitzgibbons PL, Page DL, Weaver D et al (1999) Prognostic factors in breast cancer. College of American Pathologists consensus statement. Arch Pathol Lab Med 124:966–978Google Scholar
  6. 6.
    Lyman GH, Temin S, Edge SB et al (2014) American Society of Clinical Oncology Clinical Practice. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 32(13):1365–1383CrossRefPubMedGoogle Scholar
  7. 7.
    Pesek S, Ashikaga T, Krag LE, Krag D (2012) The false-negative rate of sentinel node biopsy in patients with breast cancer: a meta-analysis. World J Surg 36(9):2239–2251. CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Agarwal G, Gambhir S, Kheruka S et al (2005) Low-cost sentinel node studies in breast cancer with indigenous blue dye & 99mTc-antimony colloid. J Japan Surg Soc 106:221Google Scholar
  9. 9.
    National Comprehensive Cancer Network. Breast Cancer (Version 1.2017). Accessed 1 January 2017
  10. 10.
    Parmar V, Hawaldar R, Nair NS et al (2013) Sentinel node biopsy versus low axillary sampling in women with clinically node negative operable breast cancer. Breast 22(6):1081–1086CrossRefPubMedGoogle Scholar
  11. 11.
    Narui K, Ishikawa T, Kito A et al (2010) Observational study of blue dye-assisted four-node sampling for axillary staging in early breast cancer. Eur J Surg Oncol 36(8):731–736CrossRefPubMedGoogle Scholar
  12. 12.
    Leong SP, Shen ZZ, Liu TJ et al (2010) Is breast cancer the same disease in Asian and Western countries? World J Surg 34(10):2308–2324. CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Agarwal G, Ramakant P, Forgach ER et al (2009) Breast cancer care in developing countries. World J Surg 33(10):2069–2076. CrossRefPubMedGoogle Scholar
  14. 14.
    Hinkle GH. Lymphoscintigraphy and sentinel node biopsy in the staging of cancer (Correspondence Continuing Education Courses for Nuclear Pharmacists and Nuclear Medicine Professionals, Volume 11, Lesson 6). Accessed 12 January 2017
  15. 15.
    Collier BD, Palmer DW, Wilson JF et al (1983) Internal mammary lymphoscintigraphy in patients with breast cancer. Radiology 147:845–848CrossRefPubMedGoogle Scholar
  16. 16.
    Agwunobi TC, Boak JL (1978) Diagnosis of malignant breast disease by axillary lymphoscintigraphy: a preliminary report. Br J Surg 65:379–383CrossRefPubMedGoogle Scholar
  17. 17.
    Sadeghi R, Zakavi SR, Forghani MN et al (2010) The efficacy of Tc-99m sestamibi for sentinel node mapping in breast carcinomas: comparison with Tc-99m antimony sulphide colloid. Nuclear Med Rev 13(1):1–4Google Scholar

Copyright information

© Société Internationale de Chirurgie 2018

Authors and Affiliations

  1. 1.Department of Endocrine and Breast SurgerySanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)LucknowIndia
  2. 2.Department of SurgerySt. John’s Medical CollegeBengaluruIndia
  3. 3.Department of PathologySanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)LucknowIndia
  4. 4.Department of Nuclear MedicineSanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)LucknowIndia

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