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Safety and Efficacy of Ga-68- or Lu-177-Labeled DOTA-IBA as a Novel Theranostic Radiopharmaceutical for Bone Metastases A Phase 0/I Study

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收录情况： ◇ SCIE

作者：
Qiu, Lin[1,2,3,*1] * ; Wang, Yingwei[1,2,3,4] * ; Liu, Hanxiang[1,2,3] * ; Wang, Qixin[1,2,3] * ; Chen, Lin[1,2,3] ; Liu, Lin[1,2,3] ; Wang, Li[1,2,3] ; Feng, Yue[1,2,3,*2] ; Chen, Yue[1,2,3,*3] ;
机构： [1]Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University [2]Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province [3]Nuclear Medicine Institute of Southwest Medical University, Luzhou [4]Department of Nuclear Medicine, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China
出处：
DOI： 10.1097/RLU.0000000000004634
ISSN：

关键词： bone metastasis theranostics Ga-68 Lu-177-DOTA-IBA dosimetry bone pain palliation

摘要：
PurposeWe designed and synthesized a novel theranostic bisphosphonate radiopharmaceutical (Ga-68- or Lu-177-labeled DOTA-ibandronic acid [Ga-68/Lu-177-DOTA-IBA]) for bone metastasis. In this study, the dosimetry, safety, and efficacy of Ga-68/Lu-177-DOTA-IBA as a theranostic radiopharmaceutical for bone metastases were evaluated in patients with malignancy based on Ga-68- and Lu-177-DOTA-IBA images, blood samples, and dosimetric analysis.Patients and MethodsEighteen patients with bone metastasis and progression under conventional therapies were included in this study. Baseline Tc-99m-MDP SPECT and Ga-68-DOTA-IBA PET/CT were performed for comparative purposes within 3 days. After receiving 891.5 +/- 301.3 MBq Lu-177-DOTA-IBA, serial Lu-177-DOTA-IBA SPECT bone scan was performed over 14 days. Dosimetric evaluation was performed for main organs and tumor lesions. Safety was assessed by blood biomarkers. Karnofsky Performance Status, pain score, and follow-up Ga-68-DOTA-IBA PET/CT were performed for response evaluation.ResultsBaseline Ga-68-DOTA-IBA PET demonstrated a higher efficacy for detecting bone metastases compared with Tc-99m-MDP SPECT. The time-activity curves showed fast uptake and high retention of Lu-177-DOTA-IBA in bone metastases (24 hours: 9.43 +/- 2.75 %IA; 14 days: 5.45 +/- 2.52 %IA). Liver, kidneys, and red marrow time-activity curves revealed a low uptake and fast clearance. The radiation-absorbed dose in bone metastasis lesions (6.40 +/- 2.13 Gy/GBq) was significantly higher than that in red marrow (0.47 +/- 0.19 Gy/GBq), kidneys (0.56 +/- 0.19 Gy/GBq), or liver (0.28 +/- 0.07 Gy/GBq), with all P's < 0.001. Compared with baseline level, only one patient developed new grade 1 leukopenia (toxicity rate, 6%). The Lu-177-DOTA-IBA therapy had no statistically significant effect on bone marrow hematopoietic function, liver function, and kidney function at any follow-up visit. Bone pain palliation was achieved in 82% (14/17) of patients. The 8-week follow-up Ga-68-DOTA-IBA PET/CT demonstrated partial response in 3 patients, disease progression in 1 patient, and stable disease in 14 patients.Conclusions(68)Ga/Lu-177-DOTA-IBA provides a set of potential theranostic radiopharmaceuticals and may have a good prospect for the management of bone metastasis.

基金：
Science and Technology Department of Sichuan Province [2023YFS0091, 2022YFS0608]; Luzhou Science and Technology Department [2021LZXNYD-J07]; Southwest Medical University [2020ZRZD009, 20087]

基金编号： 2023YFS0091 2022YFS0608 2021LZXNYD-J07 2020ZRZD009 20087

语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 3 区 医学
小类 | 3 区 核医学
最新[2023]版：
大类 | 3 区 医学
小类 | 3 区 核医学
JCR分区：
出版当年[2023]版：
Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
最新[2023]版：
Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University [2]Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province [3]Nuclear Medicine Institute of Southwest Medical University, Luzhou [*1]Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000, Sichuan, China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University [2]Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province [3]Nuclear Medicine Institute of Southwest Medical University, Luzhou [*1]Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000, Sichuan, China [*2]Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, No. 25 TaiPing St, Jiangyang District Luzhou 646000, Sichuan, China [*3]Nuclear Medicine Institute of Southwest Medical University, No. 25 TaiPing St, Jiangyang District Luzhou 646000, Sichuan, China.
推荐引用方式(GB/T 7714)：
Qiu Lin,Wang Yingwei,Liu Hanxiang,et al.Safety and Efficacy of Ga-68- or Lu-177-Labeled DOTA-IBA as a Novel Theranostic Radiopharmaceutical for Bone Metastases A Phase 0/I Study[J].CLINICAL NUCLEAR MEDICINE.2023,48(6):489-496.doi:10.1097/RLU.0000000000004634.
APA：
Qiu, Lin,Wang, Yingwei,Liu, Hanxiang,Wang, Qixin,Chen, Lin...&Chen, Yue.(2023).Safety and Efficacy of Ga-68- or Lu-177-Labeled DOTA-IBA as a Novel Theranostic Radiopharmaceutical for Bone Metastases A Phase 0/I Study.CLINICAL NUCLEAR MEDICINE,48,(6)
MLA：
Qiu, Lin,et al."Safety and Efficacy of Ga-68- or Lu-177-Labeled DOTA-IBA as a Novel Theranostic Radiopharmaceutical for Bone Metastases A Phase 0/I Study".CLINICAL NUCLEAR MEDICINE 48..6(2023):489-496

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