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

PURPOSE:

Primary 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).

METHODS:

This 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.

RESULTS:

A 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.

CONCLUSIONS:

The 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.

2023-04-04·Circulation

Gut Microbiota–Derived Trimethylamine N-Oxide Contributes to Abdominal Aortic Aneurysm Through Inflammatory and Apoptotic Mechanisms

Article

作者: Mani, Kevin ; Cameron, Scott J ; Björck, Martin ; Biddinger, Sudha ; Hazen, Stanley L ; Bhandari, Rohan ; Coughlin, Taylor M ; Tranter, Michael ; Sangwan, Naseer ; Benson, Tyler W ; Li, Xinmin S ; Wanhainen, Anders ; Helsley, Robert N ; Conrad, Kelsey A ; Wadding-Lee, Caris ; Stone, Timothy ; Brown, J Mark ; Owens, A Phillip ; Schugar, Rebecca C ; Brooks, Michael ; Buffa, Jennifer A ; Tang, W H Wilson ; Russell, Hannah M ; Pascual, Crystal ; Fleifil, Salma ; Wang, Zeneng ; Ademoya, Akiirayi

Background::

Large-scale human and mechanistic mouse studies indicate a strong relationship between the microbiome-dependent metabolite trimethylamine N-oxide (TMAO) and several cardiometabolic diseases. This study aims to investigate the role of TMAO in the pathogenesis of abdominal aortic aneurysm (AAA) and target its parent microbes as a potential pharmacological intervention.

Methods::

TMAO and choline metabolites were examined in plasma samples, with associated clinical data, from 2 independent patient cohorts (N=2129 total). Mice were fed a high-choline diet and underwent 2 murine AAA models, angiotensin II infusion in low-density lipoprotein receptor–deficient ( Ldlr −/− ) mice or topical porcine pancreatic elastase in C57BL/6J mice. Gut microbial production of TMAO was inhibited through broad-spectrum antibiotics, targeted inhibition of the gut microbial choline TMA lyase (CutC/D) with fluoromethylcholine, or the use of mice genetically deficient in flavin monooxygenase 3 ( Fmo3 −/− ). Finally, RNA sequencing of in vitro human vascular smooth muscle cells and in vivo mouse aortas was used to investigate how TMAO affects AAA.

Results::

Elevated TMAO was associated with increased AAA incidence and growth in both patient cohorts studied. Dietary choline supplementation augmented plasma TMAO and aortic diameter in both mouse models of AAA, which was suppressed with poorly absorbed oral broad-spectrum antibiotics. Treatment with fluoromethylcholine ablated TMAO production, attenuated choline-augmented aneurysm initiation, and halted progression of an established aneurysm model. In addition, Fmo3 −/− mice had reduced plasma TMAO and aortic diameters and were protected from AAA rupture compared with wild-type mice. RNA sequencing and functional analyses revealed choline supplementation in mice or TMAO treatment of human vascular smooth muscle cells–augmented gene pathways associated with the endoplasmic reticulum stress response, specifically the endoplasmic reticulum stress kinase PERK.

Conclusions::

These results define a role for gut microbiota–generated TMAO in AAA formation through upregulation of endoplasmic reticulum stress–related pathways in the aortic wall. In addition, inhibition of microbiome-derived TMAO may serve as a novel therapeutic approach for AAA treatment where none currently exist.

2015-08-01·Journal of nuclear medicine : official publication, Society 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: Fogarty, Gerald ; Kneebone, Andrew ; Jagavkar, Raj ; Tarlinton, Lisa ; Tang, Reuben ; Hickey, Adam ; Morigi, Joshua J ; Fanti, Stefano ; Nguyen, Quoc ; Hruby, George ; van Leeuwen, Pim J ; Emmett, Louise ; Stricker, Phillip D ; Ho, Bao

METHODS:

A 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.

RESULTS:

In 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).

CONCLUSION:

In 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.

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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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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


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	觸製構壓鏇餘顧衊窪繭(醖製憲範齋糧壓獵獵糧) = 簾糧夢繭積蓋蓋淵壓築鹹醖鹹鑰網選憲築醖顧 (窪糧艱餘鹽蓋顧獵糧襯, 壓顧憲衊憲憲餘簾繭鏇 ~ 蓋廠壓艱製襯鹽觸鑰鬱) 更多	-	2021-10-19
NCT01395030 (CTgov)	临床2期	肝细胞癌	64	Computed Tomography+18F-fluoromethylcholine	艱襯築簾廠壓簾觸構鏇(網窪齋鹽鹽衊繭鹽願鏇) = 廠顧憲鹹鏇膚鬱網壓網廠窪網鑰願醖憲膚鹹醖 (餘積製鹹膚觸艱憲襯憲, 齋鏇膚膚鹹衊糧鏇蓋築 ~ 糧蓋構膚衊鹽觸構糧簾) 更多	-	2018-09-26
NCT00928252 (CTgov)	临床1/2期	去势抵抗性前列腺癌	25	IV fluorine-18 labeled methylcholine before PET/CT	鬱鹹壓鑰衊範顧鹹夢壓(淵鏇醖構選齋鹽選壓壓) = 淵繭選積製蓋淵憲製蓋餘廠獵繭夢艱壓鹹鏇構 (鑰範蓋網淵積積衊齋顧, 鑰鏇餘膚觸蓋鏇夢網鏇 ~ 網積選獵簾願觸膚醖獵) 更多	-	2017-08-14
Pubmed \| Eur J Nucl Med Mol Imaging	N/A	原发性甲状旁腺功能亢进症	24	18F-Fluorocholine	壓遞廠鹽壓壓齋醖憲膚(繭蓋衊鏇製鹽淵廠鹹網) = 遞窪齋顧範範築繭廠齋襯襯壓獵選糧網願鬱艱 (壓鹽鑰獵鏇鬱顧範觸遞 ) 更多	-	2014-11-01
Pubmed \| Eur J Nucl Med Mol Imaging	N/A	原发性甲状旁腺功能亢进症	24	(99m)Tc-sestaMIBI dual-phase imaging	壓遞廠鹽壓壓齋醖憲膚(繭蓋衊鏇製鹽淵廠鹹網) = 壓鹹膚遞窪壓糧糧艱鹽襯襯壓獵選糧網願鬱艱 (壓鹽鑰獵鏇鬱顧範觸遞 ) 更多	-	2014-11-01