Nimotuzumab is an anti group of anti-epidermal growth factor receptor the EGF protein receptor, such as colorectal, brain, pancrea cervical and breast cancer. In order to obtain a of the above-mentioned cancers, nimotuzumab and gamma-emitter 177 Lu. This report discuss vivo tests, which included cytotoxicity, clearance, imaging and biodistribution tests. The cytotoxicity test of (lung carcinoma) was found unradiolabeled nimotuzumab. The on normal rats showed that the residue the urine. The biodistribution and image tests showed that 177 Lu-DOTA-nimotuzumab there organs, such as the kidney, liver and bone post injection of 177 Lu-DOTA nearly the same as or slightly lower compared to other radiolabeled monoclonal antibodies, precautions still ha tested on cancer patients.

ABSTRAK STUDI AWAL ESTIMASI DOSIS INTERNAL 177Lu-DOTA TRASTUZUMAB PADA MANUSIA BERBASIS UJI BIODISTRIBUSI PADA MENCIT. Radiofarmaka baru untuk pengobatan penyakit kanker payudara tipe HER-2, 177Lu-DOTA Trastuzumab, telah berhasil diproduksi oleh Pusat Teknologi Radioisotop dan Radiofarmaka (PTRR) BATAN. Demi keamanan produk dan keselamatan pasien, radiofarmaka baru tersebut perlu dilengkapi dengan data studi dosis internal yang dilakukan setelah uji praklinis pada hewan coba selesai. Oleh karena itu, studi ini bertujuan untuk melakukan estimasi dosis pada pasien yang dihitung berdasarkan data uji biodistribusi pada mencit. Studi Uji biodistribusi dilakukan pada 25 ekor mencit dan diamati biodistribusinya pada organ-organ, diantaranya otak, perut, usus, jantung , ginjal, hati, paru-paru, otot, tulang, limpa dan kandung kemih. Pengamatan cacahan organ dilakukan pada jam ke 1, 2, 3, 4, 24, 48 pasca injeksi radiofarmaka 177Lu DOTA-Trastuzumab sebesar 100mCi. Hasil yang diperoleh dari uji biodistribusi adalah % ID/gram organ tikus, kemudian dilakukan konversi perhitungan ke % ID/gram organ manusia. Untuk mengestimasi dosis ke manusia, hasil %ID/gram organ tersebut dipakai sebagai input pada software dosimetri internal OLINDA/EXM, dengan cara melakukan plotting %ID/gram versus waktu, yang akan menghasilkan residence time di masing-masing organ. Setelah residence time diperoleh, dosis internal radiasi pada masing-masing organ dan seluruh tubuh dapat diketahui. Hasil studi menunjukkan bahwa tiga  organ yang memiliki dosis internal tertinggi 177Lu DOTA Trastuzumab adalah : paru-paru, hati dan ovarium dengan dosis masing-masing 0,063; 0,046 dan 0,025 mSv/MBq. Disimpulkan bahwa hasil estimasi dosis internal radiasi total yang diperoleh manusia pada penyuntikan radiofarmaka 177Lu-DOTA Trastuzumab adalah 0.21 mSv/MBq. ABSTRACT   INTERNAL DOSE ESTIMATION OF 177Lu-DOTA TRASTUZUMAB IN HUMAN BASED ON THE BIODISTRIBUTION DATA OF MICE: A PRELIMINARY STUDY. A new radiopharmaceutical for treating Breast Cancer of HER-2 type, 177Lu DOTA-Trastuzumab, had been successfully produced by The Centre for Radioisotope and Radiopharmaceutical Technology-BATAN. With regard to the patient safety, the new drug development process need internal dosimetry data obtained of preclinical study in animal. Hence, this study has been objected to estimate the internal radiation dose in human by performing the biodistribution test in mice. In this study, the biodistribution test was done for 25 mice and sacrificed at 1, 2, 3, 4, 24, 48 hour after the injection of 177Lu DOTA-Trastuzumab. There were 11 organs, namely brain, stomach, intestine, heart, kidneys, liver, lungs, muscle, bone, spleen, and urinary bladder, have been investigated by observing the uptake in each organ during the proposed time. The result of biodistribution test then were being calculated into injection dose per gram human organ (%ID/gr). To estimate the internal dose in human, the data of % ID/gram in human need to be plotted to calculate the residence time which will be need as the input for OLINDA/EXM, a tool for calculating internal dosimetry in Nuclear Medicine fields. As a result, three organs that have been estimated receiving the highest internal radiation dose due to the administration of 177Lu DOTA Trastuzumab are: lungs, liver, and ovaries at approximately 0,063; 0,046 and 0,025 mSv/MBq respectively. To conclude, the total internal dose in human reference model due to the administration of 177Lu-DOTA Trastuzumab has been estimated to be 0,21 mSv/MBq.

Cancer is one of the causes of death in Indonesia and even the world. Nuclear medicine techniques with radiopharmaceuticals and SPECT are one of the ways to treat cancer, but their use in Indonesia is not yet popular. Radiopharmaceuticals marked with radionuclide emitting beta (β) radiation are proven to be used for cancer therapy, one that has been developed in PTRR-BATAN is 90Y-EDTMP. Yttrium-90 is used in nuclear medicine by utilizing β radiation (E max 2.28 MeV). The β energy which is produced from the decay process of 90Y radionuclides to 90Zr can kill cancer cells. This study aimed to provide information about the substances biological effects so that preventive measures can be taken to protect humans. This study conducted evaluation of the 90Y-marked radiopharmaceutical (90Y produced from a 90Sr / 90Y generator which is 90Y-EDTMP) encompasses clearance test, pyrogen test, and dose safety test in experimental animals. The clearance test utilized mice, the pyrogen test utilized rabbits, and the dose safety test utilized mice. The results of the clearance test showed that 90Y-EDTMP compound which was excreted in 192 hour was 49.70% through urine and 14.59% through feces. The total excretion of 90Y-EDTMP within 192 hours was 64.57%. Based on the results of clearance tests with calculations, 90Y of 90Sr / 90Y generators in 90Y-EDTMP dosage form had 84.2 hours of half-life, 36.5 hours of an effective half-life and 52.7 hours of a residence time. Pyrogen test results showed pyrogen-free. The 90Y-EDTMP dose safety test showed that the dose is safe and not deadly. The development of 90Y-EDTMP is expected to be improved to produce radiopharmaceuticals for cancer therapy in order to make a real contribution in public health services.