18F-Fluoromethylcholine(18F-Fluoromethylcholine)

概要

基本信息

药物类型

小分子化药

别名

18F-FCH-Jewish General Hospital

靶点-

作用方式-

作用机制-

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症-

非在研适应症

前列腺癌

原研机构

The Jewish General Hospital

在研机构-

非在研机构

The Jewish General Hospital

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

14

项与 18F-Fluoromethylcholine 相关的临床试验

CTRI/2022/04/042050

/ Not yet recruitingN/AIIT

Preoperative localisation of parathyroid adenoma in patients with primary hyperparathyroidism with 4D-CT versus 18F-fluorocholine PET CT: A pilot randomised controlled trial.

开始日期2022-05-01

申办/合作机构-

NCT04895631

/ Recruiting临床3期IIT

18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas

This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.

开始日期2021-06-30

申办/合作机构

The University of California, San Francisco

EUCTR2019-002729-31-ES

/ Unknown status临床4期IIT

18F-fluorocholine PET/CT in primary hyperparathyroidism with negative preoperative localization - PET/CT in hyperparathyroidism

开始日期2020-03-02

申办/合作机构-

100 项与 18F-Fluoromethylcholine 相关的临床结果

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100 项与 18F-Fluoromethylcholine 相关的转化医学

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100 项与 18F-Fluoromethylcholine 相关的专利（医药）

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4

项与 18F-Fluoromethylcholine 相关的文献（医药）

2023-09-01·European journal of nuclear medicine and molecular imaging

[¹⁸F]DCFPyL PET/CT versus [¹⁸F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study.

Article

作者: Tissot, Hubert ; García Vicente, Ana Maria ; Tamayo, Pilar ; Oprea-Lager, Daniela-Elena ; Blanc-Durand, Paul ; Vander Borght, Thierry ; Vierasu, Irina ; Rodríguez-Fernández, Antonio ; Chossat, Florence ; Drouet, Clément ; Merlin, Charles ; Robin, Philippe ; Maksud, Philippe ; García-Cañamaque, Lina ; Vallejo-Casas, Juan Antonio ; Hodolic, Marina ; Rousseau, Caroline ; Bouyeure, Anne-Charlotte ; Olivier, Pierre ; Mitjavila, Mercedes ; Bailliez, Alban ; Boos, Evelyne ; Gontier, Eric ; Mahmoud, Sinan Ben ; Gauthé, Mathieu

PURPOSEPrimary objective was to compare the per-patient detection rates (DR) of [¹⁸F]DCFPyL versus [¹⁸F]fluoromethylcholine positron emission tomography/computed tomography (PET/CT), in patients with first prostate cancer (PCa) biochemical recurrence (BCR). Secondary endpoints included safety and impact on patient management (PM).METHODSThis was a prospective, open label, cross-over, comparative study with randomized treatment administration of [¹⁸F]DCFPyL (investigational medicinal product) or [¹⁸F]fluoromethylcholine (comparator). Men with rising prostate-specific antigen (PSA) after initial curative therapy were enrolled. [¹⁸F]DCFPyL and [¹⁸F]fluoromethylcholine PET/CTs were performed within a maximum time interval of 12 days. DR was defined as the percentage of positive PET/CT scans identified by 3 central imaging readers. PM was assessed by comparing the proposed pre-PET/CT treatment with the local treatment", defined after considering both PET/CTs.RESULTSA total of 205 patients with first BCR after radical prostatectomy (73%; median PSA = 0.46 ng/ml [CI 0.16;27.0]) or radiation therapy (27%; median PSA = 4.23 ng/ml [CI 1.4;98.6]) underwent [¹⁸F]DCFPyL- and/or [¹⁸F]fluoromethylcholine -PET/CTs, between July and December 2020, at 22 European sites. 201 patients completed the study. The per-patient DR was significantly higher for [¹⁸F]DCFPyL- compared to [¹⁸F]fluoromethylcholine -PET/CTs (58% (117/201 patients) vs. 40% (81/201 patients), p < 0.0001). DR increased with higher PSA values for both tracers (PSA ≤ 0.5 ng/ml: 26/74 (35%) vs. 22/74 (30%); PSA 0.5 to ≤ 1.0 ng/ml: 17/31 (55%) vs. 10/31 (32%); PSA 1.01 to < 2.0 ng/ml: 13/19 (68%) vs. 6/19 (32%);PSA > 2.0: 50/57 (88%) vs. 39/57 (68%) for [¹⁸F]DCFPyL- and [¹⁸F]fluoromethylcholine -PET/CT, respectively). [¹⁸F]DCFPyL PET/CT had an impact on PM in 44% (90/204) of patients versus 29% (58/202) for [¹⁸F]fluoromethylcholine. Overall, no drug-related nor serious adverse events were observed.CONCLUSIONSThe primary endpoint of this study was achieved, confirming a significantly higher detection rate for [¹⁸F]DCFPyL compared to [¹⁸F]fluoromethylcholine, in men with first BCR of PCa, across a wide PSA range. [¹⁸F]DCFPyL was safe and well tolerated.

2015-08-01·Journal of Nuclear Medicine1区 · 医学

Prospective Comparison of ¹⁸F-Fluoromethylcholine Versus ⁶⁸Ga-PSMA PET/CT in Prostate Cancer Patients Who Have Rising PSA After Curative Treatment and Are Being Considered for Targeted Therapy

1区 · 医学

Article

作者: Fanti, Stefano ; Nguyen, Quoc ; van Leeuwen, Pim J ; Emmett, Louise ; Jagavkar, Raj ; Tarlinton, Lisa ; Morigi, Joshua J ; Fogarty, Gerald ; Kneebone, Andrew ; Ho, Bao ; Hruby, George ; Stricker, Phillip D ; Tang, Reuben ; Hickey, Adam

In prostate cancer with biochemical failure after therapy, current imaging techniques have a low detection rate at the prostate-specific antigen (PSA) levels at which targeted salvage therapy is effective. (11)C-choline and (18)F-fluoromethylcholine, though widely used, have poor sensitivity at low PSA levels. (68)Ga-PSMA (Glu-NH-CO-NH-Lys-(Ahx)-[(68)Ga-N,N'-bis[2-hydroxy-5-(carboxyethyl)benzyl]ethylenediamine-N,N'-diacetic acid]) has shown promising results in retrospective trials. Our aim was to prospectively compare the detection rates of (68)Ga-PSMA versus (18)F-fluoromethylcholine PET/CT in men who were initially managed with radical prostatectomy, radiation treatment, or both and were being considered for targeted therapy.METHODSA sample of men with a rising PSA level after treatment, eligible for targeted treatment, was prospectively included. Patients on systemic treatment were excluded. (68)Ga-PSMA, (18)F-fluoromethylcholine PET/CT, and diagnostic CT were performed sequentially on all patients between January and April 2015, and the images were assessed by masked, experienced interpreters. The findings and their impact on management were documented, together with the results of histologic follow-up when feasible.RESULTSIn total, 38 patients were enrolled. Of these, 34 (89%) had undergone radical prostatectomy and 4 (11%) had undergone radiation treatment. Twelve (32%) had undergone salvage radiation treatment after primary radical prostatectomy. The mean PSA level was 1.74 ± 2.54 ng/mL. The scan results were positive in 26 patients (68%) and negative with both tracers in 12 patients (32%). Of the 26 positive scans, 14 (54%) were positive with (68)Ga-PSMA alone, 11 (42%) with both (18)F-fluoromethylcholine and (68)Ga-PSMA, and only 1 (4%) with (18)F-fluoromethylcholine alone. When PSA was below 0.5 ng/mL, the detection rate was 50% for (68)Ga-PSMA versus 12.5% for (18)F-fluoromethylcholine. When PSA was 0.5-2.0 ng/mL, the detection rate was 69% for (68)Ga-PSMA versus 31% for (18)F-fluoromethylcholine, and when PSA was above 2.0, the detection rate was 86% for (68)Ga-PSMA versus 57% for (18)F-fluoromethylcholine. On lesion-based analysis, (68)Ga-PSMA detected more lesions than (18)F-fluoromethylcholine (59 vs. 29, P < 0.001). The tumor-to-background ratio in positive scans was higher for (68)Ga-PSMA than for (18)F-fluoromethylcholine (28.6 for (68)Ga-PSMA vs. 9.4 for (18)F-fluoromethylcholine, P < 0.001). There was a 63% (24/38 patients) management impact, with 54% (13/24 patients) being due to (68)Ga-PSMA imaging alone. Histologic follow-up was available for 9 of 38 patients (24%), and 9 of 9 (68)Ga-PSMA-positive lesions were consistent with prostate cancer ((68)Ga-PSMA was true-positive). The lesion positive on (18)F-fluoromethylcholine imaging and negative on (68)Ga-PSMA imaging was shown at biopsy to be a false-positive (18)F-fluoromethylcholine finding ((68)Ga-PSMA was true-negative).CONCLUSIONIn patients with biochemical failure and a low PSA level, (68)Ga-PSMA demonstrated a significantly higher detection rate than (18)F-fluoromethylcholine and a high overall impact on management.

2014-11-01·European Journal of Nuclear Medicine and Molecular Imaging

18F-Fluorocholine PET/CT for localization of hyperfunctioning parathyroid tissue in primary hyperparathyroidism: a pilot study

Article

作者: Lezaic, Luka ; Fettich, Jure ; Sever, Mojca Jensterle ; Kocjan, Tomaz ; Hocevar, Marko ; Rep, Sebastijan

PURPOSEPrimary hyperparathyroidism is a common endocrine disorder which is diagnosed biochemically and for which therapy is surgical. A prerequisite for minimally invasive surgery, which minimizes morbidity and cost, is accurate localization of the involved gland(s). The aim of this study was to evaluate the usefulness of (18)F-fluorocholine PET/CT for preoperative localization of hyperfunctioning parathyroid tissue.METHODS(18)F-Fluorocholine PET/CT and conventional parathyroid scintigraphic imaging consisting of (99m)Tc-sestaMIBI SPECT/CT, (99m)Tc-sestaMIBI dual-phase imaging and (99m)Tc-sestaMIBI/pertechnetate subtraction imaging were performed in 24 patients. The diagnostic performance of the imaging methods was compared against histology as the gold standard and postoperative serum Ca(2+) and iPTH values.RESULTSThe sensitivity and specificity of (18)F-fluorocholine PET/CT were 92% and 100%, respectively, in contrast to 49% and 100%, 46% and 100%, and 44% and 100% for (99m)Tc-sestaMIBI SPECT/CT, (99m)Tc-sestaMIBI/pertechnetate subtraction imaging and (99m)Tc-sestaMIBI dual-phase imaging, respectively. Combined conventional scintigraphic imaging had a sensitivity and specificity of 64% and 100%, respectively. The performance of (18)F-fluorocholine PET/CT was superior particularly in patients with multiple lesions or hyperplasia.CONCLUSION(18)F-Fluorocholine PET/CT appears to be a promising, effective imaging method for localization of hyperfunctioning parathyroid tissue.

1

项与 18F-Fluoromethylcholine 相关的新闻（医药）

2023-07-21

·GlobeNewswire-Health Care

Curium Announces Publication of [18F]DCFPyL Versus [18F]Fluoromethylcholine Results From European Phase III Study (PYTHON Trial)

PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer. The results of the PYTHON trial were published online ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023. Today’s announcement follows the May 2023 recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency to grant a marketing authorization for PYLCLARI® (piflufolastat (18F)) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer – based on the Phase III PYTHON clinical trial conducted in Europe and the Phase III OSPREY and CONDOR clinical trials conducted in the U.S. Dr. Daniela E. Oprea-Lager| Assoc. Professor in Nuclear Medicine, MD PhD, Amsterdam UMC (lead author of the PYTHON Manuscript submitted to the European Journal of Nuclear Medicine and Molecular Imaging) commented: “Adequate restaging of patients with biochemically relapsed prostate cancer is essential for guiding clinicians on how to choose the optimal treatment strategy with the maximum benefit for the patients. PYTHON trial demonstrates the superiority of [18F]DCFPyL above [18F]fluoromethylcholine PET/CT paving the way towards individualized therapy.” Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented: “[18F]fluoromethylcholine has been the current approved and established standard for PET/CT imaging of prostate cancer in Europe, and the publication of this manuscript validates our success in developing new diagnostic imaging solutions – as we continue on our journey to redefine the experience of cancer through our trusted legacy in nuclear medicine.” In the U.S., piflufolastat (18F) was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY® and sold by Lantheus. The PYTHON publication in European Journal of Nuclear Medicine and Molecular Imaging can be found here. PYTHON Study The PYTHON Study (NCT04734184) was a Phase III, European, multicenter, prospective cross-over trial, to evaluate and compare the detection rates, impact on patient management and safety proﬁles of [18F]DCFPyL and [18F]fluoromethylcholine, in patients with first biochemical recurrence after initial definitive therapy with curative intent. This study successfully met the primary endpoint. About PYLARIFY® (piflufolastat F 18, also known as [18F]DCFPyL) Injection PYLARIFY® (piflufolastat F 18) injection (also known as [18F]DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6 PYLARIFY is FDA-approved and commercialized in the U.S. by Lantheus. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2019. About CuriumCurium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross BethellVP, Head of Global Communicationscommunications@curiumpharma.com 1Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.20201916892Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.3Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.4Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.5Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-02906PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company

临床3期上市批准临床结果放射疗法

100 项与 18F-Fluoromethylcholine 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
前列腺癌	临床3期	加拿大	The Jewish General Hospital	2016-09-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2023	N/A	前列腺癌	-	18F-FluorocholineRadium 223 dichloride (18F-Fluorocholine PET/CT)	(積構廠齋鬱獵壓顧遞選) = median OS of 16 months 範製膚觸糧醖醖顧築餘 (壓壓膚鏇窪齋糧繭夢遞 ) 更多	-	2023-08-28
SNMMI2023	N/A	前列腺癌	-	223Ra therapy		-	2023-08-28
EANM2022	N/A	甲状腺髓样癌 calcitonin \| CEA levels	-	18F-Fluorocholine (Neck-US)	築艱積選範網衊鹹膚願(憲鏇範遞築窪廠蓋網窪) = 製壓蓋蓋觸鏇醖鏇鹹壓壓窪夢鹽蓋糧襯遞窪鬱 (選壓憲築顧憲積鏇膚鬱 ) 更多	-	2022-09-22
EANM2022	N/A	复发性前列腺癌	-	18F-DCFPyL	網觸選鏇鏇鬱齋簾壓鑰(遞憲壓膚鏇願構蓋積餘) = 遞製憲糧醖醖壓鑰淵築構構餘衊簾廠鹹鬱簾鹹 (衊襯製構鬱遞遞遞蓋獵 ) 更多	-	2022-09-22
EANM2022	N/A	复发性前列腺癌	-	18F-Fluorocholine	網觸選鏇鏇鬱齋簾壓鑰(遞憲壓膚鏇願構蓋積餘) = 遞齋膚齋顧餘鹽鹽鬱鏇構構餘衊簾廠鹹鬱簾鹹 (衊襯製構鬱遞遞遞蓋獵 ) 更多	-	2022-09-22
NCT03764007 (CTgov)	临床2/3期	原发性甲状旁腺功能亢进症 \| 甲状旁腺腺瘤	98	Positron Emission Tomography (PET)+18F-Fluorocholine	糧淵觸壓遞餘艱餘遞網(夢積遞蓋繭鑰積鹽遞憲) = 繭憲艱願壓壓齋選齋獵簾餘艱簾窪衊願築窪膚 (鑰憲顧窪醖壓簾齋網醖, 鏇夢鑰願鏇顧鑰廠淵憲 ~ 遞簾鬱鬱製範淵鑰積築) 更多	-	2021-10-19
EANM2021	N/A	复发性前列腺癌	-	18F-fluorocholine (FCH-PET/CT + SBRT)	(餘範鹹築壓獵鑰艱餘構) = 廠範顧獵構範糧鑰糧襯觸艱憲鹹選願廠鬱簾構 (願淵鬱繭壓膚夢鹹淵鬱, 4.13 ~ 13.9)	不佳	2021-09-24
EANM2021	N/A	原发性甲状旁腺功能亢进症	35	¹⁸F-Fluoromethylcholine (Neck USG)	(積淵構構構餘繭憲選衊) = 艱簾壓壓遞襯壓醖鏇遞憲衊齋鏇憲齋範膚製壓 (構醖窪蓋鑰製窪憲獵範 ) 更多	积极	2021-09-24
EANM2021	N/A	原发性甲状旁腺功能亢进症	35	¹⁸F-Fluoromethylcholine (99mTc-MIBI)	(積淵構構構餘繭憲選衊) = 糧構積簾鏇積襯簾餘蓋憲衊齋鏇憲齋範膚製壓 (構醖窪蓋鑰製窪憲獵範 ) 更多	积极	2021-09-24
EANM2021	N/A	去势抵抗性前列腺癌 \| 骨转移癌	48	radium-22318F-fluorocholine (Bone scintigraphy + 18F-fluorocholine PET/CT)	(艱糧衊鬱糧願築憲廠餘) = 製鑰艱簾淵鏇積範鑰鹽簾壓構遞襯選簾獵餘窪 (鹽繭鹽憲鹹製膚淵襯齋 )	-	2021-09-24
EANM2021	N/A	复发性前列腺癌	68	18F-Fluciclovine PET/CT	夢顧鏇鑰築繭鏇衊襯鬱(醖繭壓構衊鹹夢鹹獵積) = 願網鏇衊獵鹹範窪簾範製鏇齋憲膚窪繭淵鹹淵 (繭觸鏇廠繭範鹽襯遞窪 )	积极	2021-09-24
EANM2021	N/A	复发性前列腺癌	68	18F-Fluorocholine18F-Fluciclovine (18F-Fluorocholine PET/CT)	夢顧鏇鑰築繭鏇衊襯鬱(醖繭壓構衊鹹夢鹹獵積) = 繭鬱艱膚遞鏇夢顧膚鑰製鏇齋憲膚窪繭淵鹹淵 (繭觸鏇廠繭範鹽襯遞窪 )	积极	2021-09-24
SNMMI2021	N/A	甲状旁腺腺瘤	-	18F-fluorocholine (Sestamibi imaging)	繭餘蓋窪繭壓艱製艱蓋(淵築鹹製壓憲顧選鹹鑰) = 遞築鏇顧遞夢鏇築築網構築淵簾鹽積齋窪壓製 (窪鹹鬱遞觸簾蓋淵鹽繭, 0.10 ~ 0.27)	-	2021-05-18
NCT01395030 (CTgov)	临床2期	肝细胞癌	64	Computed Tomography+18F-fluoromethylcholine	齋齋蓋淵鹽鏇簾願觸艱(網鑰窪繭簾憲窪築鹹網) = 窪蓋範鹹遞齋廠選鬱膚壓餘鑰艱積餘遞製廠齋 (範觸範淵鬱廠醖簾艱糧, 襯艱獵獵憲積繭獵淵鑰 ~ 夢糧築窪憲艱簾繭壓鑰) 更多	-	2018-09-26