Abstract:
:Radium-223 dichloride (Ra-223) is the first targeted alpha therapy approved for the treatment of patients with castration-resistant prostate cancer (CRPC) with bone metastasis. Ra-223 improved overall survival in the international Phase III ALSYMPCA (ALpharadin in SYMPtomatic Prostate Cancer) study. Ra-223 was also demonstrated to be efficacious and safe in Japanese patients in Phase I and Phase II clinical trials. Ra-223 was approved in Japan for the treatment of patients with CRPC with bone metastasis in 2016. The conduct of clinical studies with radionuclides in Japan involves mandatory compliance with local and international regulations pertaining to radiation protection. Without an existing Japanese framework for the handling of α-emitters in clinical practice, we encountered many challenges to initiate the clinical studies. Therefore, we started on a project to determine best practice on the use of Ra-223 in clinical studies. For this project, we evaluated all applicable laws and regulations on the use of radionuclides in medicine, then examined whether and how the α-emitter Ra-223 could meet these legal and regulatory requirements. This included how to approach the matter of discharging patients administered Ra-223 from hospital and radiation protection for caregivers, general public and medical care professionals. Subsequently, we published Manual on the proper use of radium-223 dichloride injection in clinical trials that summarized the essential requirements necessary to allow the safe use of Ra-223 in clinical trials in Japan. As the result, we succeeded in demonstrating that clinical trials of an α-emitter, Ra-223, could be implemented safely in Japan. Our experience in Japan highlights the importance of a multidisciplinary team-based approach and continued professional training in a clinical setting. This article summarizes the rationale behind the development of this manual. We hope that by sharing our experience and information, we can help other countries considering the introduction of radionuclides for clinical use, and support the future development of radionuclide therapies in a safe and effective manner.
journal_name
Ann Nucl Medjournal_title
Annals of nuclear medicineauthors
Hosono M,Ikebuchi H,Nakamura Y,Yanagida S,Kinuya Sdoi
10.1007/s12149-018-1317-1subject
Has Abstractpub_date
2019-03-01 00:00:00pages
211-221issue
3eissn
0914-7187issn
1864-6433pii
10.1007/s12149-018-1317-1journal_volume
33pub_type
杂志文章abstract::125I-2'-iodospiperone (2'-ISP), which has a high and selective affinity for dopamine D2 receptors, produced a high myocardial accumulation of radioactivity in the early phase after intravenous injection into mice. A human scintigraphic study also showed that the myocardium was clearly visualized soon after intravenous...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03164959
更新日期:1993-08-01 00:00:00
abstract::16alpha-[(18)F]Fluoro-17beta-estradiol (FES) is an estrogen receptor (ER) ligand used for the detection of ER-positive malignant tumors such as breast cancer. We recently reported the feasibility of combined FES-and 2-[(18)F]fluoro-2-deoxy-D-glucose (FDG)-positron emission tomography (PET) scans for the differential d...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-007-0075-2
更新日期:2008-01-01 00:00:00
abstract::Technetium-99m tetrofosmin and thallium-201 lung SPECT imaging were performed in a patient with adenocarcinoma of the lung. Significant activities in the lung lesion were clearly depicted on both technetium-99m tetrofosmin and thallium-201 SPECT imaging. The early uptake, delayed uptake ratios and retention indices of...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03165069
更新日期:1996-02-01 00:00:00
abstract:UNLABELLED:We assessed Takotsubo (ampulla) cardiomyopathy compared with acute coronary syndrome (ACS) using two-dimensional echocardiography and 99mTc-tetrofosmin myocardial SPECT. METHODS:We examined 10 patients with Takotsubo cardiomyopathy and 16 with ACS at the time of emergency admission (acute phase), at three t...
journal_title:Annals of nuclear medicine
pub_type: 临床试验,杂志文章
doi:10.1007/BF02988449
更新日期:2003-04-01 00:00:00
abstract:OBJECTIVE:A positron emission tomography (PET) scanner using a silicon photomultiplier (SiPM PET) in place of a photomultiplier tube significantly improves the spatial and time resolution. It may also improve the evaluation of smaller lesions compared to conventional (non-SiPM) PET scanners. We compared the maximum sta...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-020-01489-0
更新日期:2020-09-01 00:00:00
abstract::Tl-201 SPECT and Tc-99m-Human serum albumin (HSA) multigated radionuclide ventriculography were performed on 11 patients with progressive muscular dystrophy (Becker type 2, Fukuyama type 2, Limb-girdle type 7) to evaluate myocardial involvement. Hypoperfusion was detected in 8 patients on Tl-201 SPECT. Decreases in bo...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03164989
更新日期:1994-02-01 00:00:00
abstract::Eight patients were inadvertently administered, and imaged with, 99mTc-labeled MDP which was 45 months expired. Two cases are presented. All patients were subsequently imaged with normal MDP. The images obtained with expired MDP were clinically acceptable. No differences in scan abnormalities were observed compared wi...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03164879
更新日期:1999-10-01 00:00:00
abstract::Alzheimer's disease (AD) is on the rise all over the world, and brings with it great challenges to medical care and heavy burdens to family and society. Accurate diagnosis and differential diagnosis are of great importance. Tau positron emission tomography (PET) might offer novel insights and be of great assistance in...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章,评审
doi:10.1007/s12149-020-01566-4
更新日期:2021-01-18 00:00:00
abstract::We quantitated the protective effect of verapamil on reperfusion injury in canine myocardial infarct using 111In-anticardiac myosin antibody and correlated to the electronmicroscopic findings. Experimental myocardial infarction was performed by one hour occlusion of the anterior descending coronary artery and followed...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03164623
更新日期:1991-09-01 00:00:00
abstract:OBJECTIVE:Estimation of myocardial blood flow (MBF) and coronary flow reserve (CFR) by SPECT myocardial perfusion imaging (MPI) remains challenging. Our aim was to approximate MBF and CFR by quantifying the absolute Tc-99m tetrofosmin retention in the myocardium via gated-SPECT/CT MPI. METHODS:Tracer retention was cal...
journal_title:Annals of nuclear medicine
pub_type: 临床试验,杂志文章
doi:10.1007/s12149-015-0982-6
更新日期:2015-08-01 00:00:00
abstract::Pyothorax-associated lymphoma (PAL) is a non-Hodgkin's lymphoma developing in the pleural cavity after a long-standing history of chronic pyothorax (CP). F-18 fluorodeoxyglucose positron emission tomography (FDG-PET) imaging is a useful modality for determination of disease extent of various malignant tumors, includin...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF02985123
更新日期:2005-12-01 00:00:00
abstract::We present a rare case of occult low-grade myofibroblastic sarcoma (LGMFS) detected by marked 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG) uptake on positron emission tomography (PET). A 46-year-old woman presented with abnormal FDG uptake in her back when FDG-PET was performed for cancer screening. The maximum stan...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-008-0194-4
更新日期:2008-11-01 00:00:00
abstract:AIM:The presence of an elevated copper concentration in cancer cells may be potentially used to differentiate healthy from transformed cells. In this study, we aimed to look at the possible role of (64)CuCl2 PET/CT in staging of patients with prostate cancer (PC). METHODS:Seven patients affected by histologically conf...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-015-0968-4
更新日期:2015-07-01 00:00:00
abstract:OBJECTIVE:To assess the diagnostic value of fluorine-18 fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) using standard uptake values (SUV) in the differential diagnoses of indeterminate pulmonary nodules. Specifically, we assessed the probability of malignancy for various SUV ranges, and compared the di...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-007-0112-1
更新日期:2008-04-01 00:00:00
abstract::We report a case of myocardial stunning after acute myocardial infarction. In the hyperacute phase of myocardial infarction, the patient's coronary arteries showed normal features on coronary angiography during extensive ST-segment elevation observed on a standard 12-lead electrocardiogram and extensive akinesis obser...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03165021
更新日期:1994-05-01 00:00:00
abstract:OBJECTIVE:We digested anti-MUC1 monoclonal antibody PR81 to produce F(ab')₂ fragments. A comparison was performed between the two radiolabeled PR81 and F(ab')₂ fragments for breast tumor imaging in a mouse model. METHODS:The optimum conditions for pepsin digestion of PR81 were investigated in terms of enzymes: antibod...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-010-0434-2
更新日期:2011-02-01 00:00:00
abstract::Metastatic calcification is often detected by bone scintigraphy. We recently saw metastatic calcification in the stomach and kidneys of a patient on continuous ambulatory peritoneal dialysis. Tc-99m HMDP accumulation into both organs was noted even in the first frame of dynamic data acquisition of 4 min/frame, suggest...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03164806
更新日期:1996-11-01 00:00:00
abstract:OBJECTIVE:Single photon emission computed tomography (SPECT) images provide many details of the anatomical structure. Also about bone scintigraphy, there are many reports of the improvement of diagnosis by SPECT images. Although SPECT is useful, it requires much time. So to perform SPECT for all cases is difficult in t...
journal_title:Annals of nuclear medicine
pub_type: 临床试验,杂志文章
doi:10.1007/BF02985048
更新日期:2005-10-01 00:00:00
abstract::A case of calcifying soft tissue malignant fibrous histiocytoma (MFH) which showed a concentration of Tc-99m MDP and Ga-67 citrate, is presented. Tc-99m MDP and Ga-67 citrate scintigraphies of the thigh mass were correlated with conventional radiography, computed tomography (CT) and angiography. ...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03164794
更新日期:1993-02-01 00:00:00
abstract:OBJECTIVES:This study was designed to investigate the efficacy of 99mtechnetium-three polyethylene glycol spacers-arginine-glycine-aspartic acid ([99mTc]3PRGD2) in the evaluation of patients with esophageal cancer. METHODS:Twenty-nine patients with a suspected esophageal lesion and for whom definite pathological diagn...
journal_title:Annals of nuclear medicine
pub_type: 临床试验,杂志文章
doi:10.1007/s12149-018-1315-3
更新日期:2019-02-01 00:00:00
abstract:UNLABELLED:We studied the causative mechanism of ampulla (Takotsubo) cardiomyopathy. METHODS:We examined 7 patients with ampulla cardiomyopathy by means of coronary angiography, two-dimensional echocardiography and 99Tc-tetrofosmin myocardial SPECT at the time of emergency admission (acute phase), at 3 to 5 days after...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF02988242
更新日期:2001-08-01 00:00:00
abstract:OBJECTIVE:Positron emission tomography (PET) angiography utilizes early dynamic PET acquisitions for depiction of the arterial vasculature. The aim of this study was to assess image quality and to evaluate feasibility of F-18 FDG PET angiography of the abdominal arteries. METHODS:Twenty-seven patients were included in...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-014-0930-x
更新日期:2015-02-01 00:00:00
abstract:OBJECTIVE:One mechanism that may be responsible for drug resistance in epilepsy is the upregulation of P-glycoprotein (P-gp), a drug efflux pump, at the epileptogenic focus. In this study, we sought to evaluate the potential of a recently developed P-gp PET radiotracer, [(11)C]N-desmethyl-loperamide ([(11)C]dLop), for ...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-013-0725-5
更新日期:2013-08-01 00:00:00
abstract::By means of Tc-99m dimercaptosuccinic acid (DMSA) scintigraphy, an established method for assessing renal cortical damage, we evaluated the pick-up rate for renal defects (scars) by single photon computed tomography (SPECT) and planar images of 10 normal volunteers, and 58 patients (70 scintigrams) with upper urinary ...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03164610
更新日期:1991-03-01 00:00:00
abstract::We present a comprehensive review of Neuroendocrine Tumors (NET) and the current and developing imaging and therapeutic modalities for NET with emphasis on Nuclear Medicine modalities. Subsequently, nanotechnology and its emerging role in cancer management, especially NET, are discussed. The article is both educative ...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章,评审
doi:10.1007/s12149-018-1235-2
更新日期:2018-04-01 00:00:00
abstract:OBJECTIVE:Technetium etarfolatide ((99m)Tc-EF) is a radioactive diagnostic imaging agent that was developed to assess the expression of folate receptors in tumors. Administering folic acid prior to the administration of (99m)Tc-EF has been shown to improve SPECT images. Here, we conducted a phase I clinical trial to as...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-015-1006-2
更新日期:2015-11-01 00:00:00
abstract:OBJECTIVE:4-Benzyl-1-(3-iodobenzylsulfonyl)piperidine, 4-B-IBSP, has shown high-binding affinity to both sigma (σ) receptors in our previous work. In current study, radiolabeling and preclinical evaluation of 4-benzyl-1-(3-[125I]-iodobenzylsulfonyl)piperidine, 4-B-[125I]IBSP, in human ductal breast carcinoma (T47D) cel...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-017-1161-8
更新日期:2017-05-01 00:00:00
abstract:OBJECTIVE:The main aim of this work is to build a robust Convolutional Neural Network (CNN) algorithm that efficiently and quickly classifies bone scintigraphy images, by determining the presence or absence of prostate cancer metastasis. METHODS:CNN, widely applied in medical image classification, was used for bone sc...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/s12149-020-01510-6
更新日期:2020-11-01 00:00:00
abstract::We report a patient with DTPA and DMSA uptake on unsuspected bone metastases. He had severe pain due to grade 3 hydronephrosis of his left kidney. When Tc-99m DTPA and DMSA renal scanning were performed for preoperative evaluation, abnormal radiopharmaceutical uptake on the iliac area was noted. Pancreatic adenocarcin...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF02987249
更新日期:2006-06-01 00:00:00
abstract::123I-BMIPP (beta-methyl-iodophenyl pentadecanoic acid) has shown unique properties for potential use in assessing myocardial metabolism. Previous basic and clinical studies demonstrated that the disturbances of myocardial metabolism precede the occurrence of myocardial perfusion abnormalities by using 201Tl in hypertr...
journal_title:Annals of nuclear medicine
pub_type: 杂志文章
doi:10.1007/BF03165056
更新日期:1996-02-01 00:00:00