JOURNAL DESCRIPTION
The Medical Radiology and Radiation Safety journal ISSN 1024-6177 was founded in January 1956 (before December 30, 1993 it was entitled Medical Radiology, ISSN 0025-8334). In 2018, the journal received Online ISSN: 2618-9615 and was registered as an electronic online publication in Roskomnadzor on March 29, 2018. It publishes original research articles which cover questions of radiobiology, radiation medicine, radiation safety, radiation therapy, nuclear medicine and scientific reviews. In general the journal has more than 30 headings and it is of interest for specialists working in thefields of medicine¸ radiation biology, epidemiology, medical physics and technology. Since July 01, 2008 the journal has been published by State Research Center - Burnasyan Federal Medical Biophysical Center of Federal Medical Biological Agency. The founder from 1956 to the present time is the Ministry of Health of the Russian Federation, and from 2008 to the present time is the Federal Medical Biological Agency.
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Medical Radiology and Radiation Safety. 2022. Vol. 67. № 3
A.A. Labushkina1, O.E. Klement’eva1, G.E. Kodina1,
N.V. Silaeva2, O.E. Lukina2, P.I. Krzhivitskii3, S.N. Novikov3
Clinical Study of the Drug «Nanotech, 99mTc» for the Detection
of Sentinel Lymph Nodes in Patients with Breast Cancer
1A.I. Burnazyan Federal Medical Biophysical Center, Moscow, Russia
2LTD «DIAMED», Moscow, Russia
3N.N. Petrov NMRC of Oncology, St. Petersburg, Russia
Contact person: Anna A. Labushkina. E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
ABSTRACT
Purpose: To evaluate the diagnostic efficacy and safety of the use of the radiopharmaceutical drug “Nanotech, 99mTc” in the detection of sentinel lymph nodes (SLN) in malignant breast cancer by indirect radionuclide lymphography and intraoperative radiometry.
Material and methods: The results of clinical studies of the drug «Nanotech, 99mTc», conducted in two research centers: N.N.Petrov National Medical Research Center of Oncology (128 patients) and N.N. Blokhin National Medical Research Center of Oncology
(20 patients), were analyzed in 148 patients with breast cancer, aimed at sectoral breast resection, radical or subcutaneous mastectomy. The patients included in the clinical trials met all the requirements of the inclusion/non-inclusion criteria assessed at the screening stage. Radiopharmaceutical drug “Nanotech, 99mTc” was injected into the affected mammary gland at 4 mutually perpendicular points intradermally periareolar. The administered activity was 20.0–40.0 MBq for each injection site, the volume of administered drug «Nanotech, 99mTc» was 0.1–0.3 ml for each injection site. The total single administered dose was 80–160 MBq in a volume of 0.4–
1.2 ml. 1–2 hours after administration of the drug, 4–24 hours before surgery, the patients underwent planar polypositional scintigraphy in three standard projections with a marker mark applied to the patient’s skin surface corresponding to the projection of each SLN. The procedure of intraoperative radiometry was performed using a specialized portable gamma detector in the operating room during the main surgical intervention. The main efficiency parameter was the frequency of identification of SLN during intraoperative radiometry, safety indicators were considered adverse events. When evaluating the results, all adverse events that occurred during the study were considered, and their relationship with the drug under study was also evaluated. For statistical analysis, the patients were divided into the following populations: FAS – all patients who received a dose of the finished drug; ITT population – all patients who received a dose of the finished drug and who underwent intraoperative radiometry; PP population – all patients who completed the study in accordance with the protocol. The main efficiency analysis was carried out in the ITT population. The safety analysis was carried out in the FAS population.
Results: The frequency of detection of SLN during intraoperative radiometry in 148 patients, in the main efficacy population (ITT), was 142/148 (95.95 %) with a one-sided 95 % confidence interval of 92.24 %, while the width of the lower part of the confidence interval was 3.71 %. Based on the analysis of primary efficacy, a conclusion was made about diagnostic efficacy, since the boundary of the one-sided
95 % confidence interval for the frequency of detection of SLN during intraoperative radiometry exceeds 84 %, while the width of the lower part of the 95 % one-sided interval does not exceed 5 %. When analyzing secondary endpoints in the ITT population, the frequency of detection of hyperfixation foci during diagnostic lymphoscintigraphy was 97.30 % with a one-sided 95 % confidence interval
of 93.97 %, while the width of the lower part of the confidence interval was 3.33 %. The results of the analysis of primary and secondary endpoints of diagnostic effectiveness in the PP population were similar to those obtained in the main population of the effectiveness assessment (ITT). The analysis of diagnostic effectiveness, carried out depending on the method of statistical analysis of the primary variable of effectiveness, led to consistent conclusions. No adverse events were registered during the study. The assessment of safety and tolerability based on the results of statistical assessments of vital signs and the condition of the skin at the injection site showed a high degree of safety and tolerability of drug “Nanotech, 99mTc”.
Conclusions: This study obtained data confirming the diagnostic efficacy and high degree of safety and tolerability of radiopharmaceutical drug “Nanotech, 99mTc”, which justifies the possibility of its medical use and registration.
Keywords: breast cancer, clinical trials, “Nanotech, 99mTc”, scintigraphy, intraoperative radiometry, sentinel lymph nodes
For citation: Labushkina AA, Klementyeva OE, Kodina GE, Silaeva NV, Lukina OE, Krzhivitskii PI, Novikov SN. Clinical study of the radiopharmaceutical drug “Nanotech, 99mTc” to identify sentinel lymph nodes in patients with breast cancer. Medical Radiology and Radiation Safety. 2022;67(3):75–82. (In Russian). DOI:10.33266/1024-6177-2022-67-3-75-82
References
1. Feggi L., Querzoli P., Prandini N., et al. Sentinel Node Study in Early Breast Cancer. Tumori Journal. 2000;86;4:314-316. doi:10.1177/030089160008600414.
2. Nieweg O., Rijk M., Olmos R., Hoefnagel C. Sentinel Node Biopsy and Selective Lymph Node Clearance – Impact on Regional Control and Survival in Breast Cancer and Melanoma. Eur. J. Nucl. Med. Mol. Imaging. 2005;32;6:631-634. doi:10.1007/s00259-005-1801-4.
3. Kanaev S.V., Novikov S.N., Semiglazov V.F., Krivorotko P.V., Zhukova L.A., Krizhevitsky P.I. The Possibility of Early Detection of Breast Cancer Neoplasms Using Ultrasound and Radionuclide Diagnostic Methods. Voprosy onkologii = Problems in Oncology. 2011;57;5:622-626 (In Russian).
4. Bourez R., Rutgers E., Van deVelde C. Will we Need Lymph Node Dissection at all in the Future? Clinical Breast Cancer. 2002;3;5:315-322.
5. Krag D.N., Anderson S.J., Julian T.B. et al. 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. 2007;8:881-888.
6. Krzhivitskiy P.I., Kanayev S.V., Novikov S.N., Ilin N.D., Novikov R.V. The Use of SPECT-CT for Visualization of Signaling Lymph Nodes and Lymph Outflow Pathways in Patients with Prostate Cancer. Voprosy onkologii = Problems in Oncology. 2016;62;2:272-276 (In Russian).
7. Diaz J.P., Gemignani M.L., Pandit-Taskar N., Park K.J., Murray M.P., Chi D.S., Sonoda Y., Barakat R.R., Abu-Rustum N.R. Sentinel Lymph Node Biopsy in the Management of Early-Stage Cervical Carcinoma. Gynecol Oncol 2011;120:347-52.
8. Recht A., Pierce S.M., Abner A., et al. Regional Nodal Failure after Conservative Surgery and Radiotherapy for Early-Stage Breast Carcinoma. J. Clin. Oncol. 1991;9:988-996.
9. Krivorotko P.V., Tabagua T.T., Komyakhov A.V., et al. Biopsy of Signaling Lymph Nodes in Early Breast Cancer: the Experience of the N.N. Petrov Research Institute of Oncology. Voprosy onkologii = Problems in Oncology. 2017;63;2:267-273 (In Russian).
10. Wong J.H., Steinemann S., Jehoon K.P., Wong D.L. Lymphoscintigraphy in Breast Cancer: the Value of Breast Lymphoscintigraphy in Breast Sentinel Node Staging. Clinical Nuclear Medicine. 2001;26;6:502-505.
11. Krivorotko P.V., Kanayev S.V., Semiglazov V.F., Novikov S.N., Krzhivitskiy P.I., Semenov I.I., et al. Methodological Problems of Signal Lymph Node Biopsy in Breast Cancer Patients. Voprosy onkologii = Problems in Oncology. 2015;61;3:418-442 (In Russian).
12. NANOCIS. Kit for the Preparation of Technetium [99mTc] Colloidal Rhenium Sulphide Injection (Nanocolloid). Summary of Product Characteristics. CIS Bio International, Member of IBA Group. T1700nE (T1700 – T1711 – T1717 – T1732 – T1716). 08/2008.
13. Summary of Product Characteristics Nanocis CRN009L3G 09 October 2020.
14. Kanayev S.V., Novikov S.N. The Role of Radionuclide Imaging of Lymph Outflow Pathways in Determining Indications for Irradiation of Parasternal Lymph Nodes. Voprosy onkologii = Problems in Oncology. 2015;61;5:737-744 (In Russian).
15. Novikov S.N., Krzhivitskii P.I., Melnik Y.S., Valitova A.A., Bryantseva Z.V., Akulova I.A., Kanaev S.V. Atlas of Sentinel Lymph Nodes in Early Breast Cancer Using Single-Photon Emission Computed Tomography: Implication for Lymphatic Contouring // Radiat Oncol J. 2021;39;1:8-14.
PDF (RUS) Full-text article (in Russian)
Conflict of interest. The authors declare no obvious and potential conflicts of interest related to the publication of this article.
Financing. The study was carried out with the sponsorship of LTD «Diamed», Moscow.
Contribution. Article was prepared with equal participation of the authors.
Article received: 17.01.2022. Accepted for publication: 15.03.2022.