A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

开始日期2018-06-05

申办/合作机构

GE Healthcare Holdings, Inc.

[+1]

NCT01085162 / WithdrawnN/A

An Open-Label Prospective, Non-Randomized, International, Multi-center, Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in Patients Suspected of Coronary Artery Disease (CAD)

This long-term study will follow patients with known or suspected of having coronary artery disease (CAD) and have participated in present and future BMS747158 clinical studies. The purpose of this study is to evaluate the long-term predictive value associated with BMS747158 Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI).

开始日期2013-03-01

申办/合作机构

Lantheus Medical Imaging, Inc.

NCT01681524 / Withdrawn临床3期

A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD)

The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.

开始日期2012-11-01

申办/合作机构

Lantheus Medical Imaging, Inc.

100 项与 Flurpiridaz F-18 相关的临床结果

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100 项与 Flurpiridaz F-18 相关的转化医学

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100 项与 Flurpiridaz F-18 相关的专利（医药）

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项与 Flurpiridaz F-18 相关的文献（医药）

2023-12-01·European journal of nuclear medicine and molecular imaging

Integrated myocardial flow reserve (iMFR) assessment: optimized PET blood flow quantification for diagnosis of coronary artery disease

Article

作者: Poitrasson-Rivière, Alexis ; Murthy, Venkatesh L ; Weinberg, Richard L ; Arida-Moody, Liliana ; Ficaro, Edward P ; Al-Mallah, Mouaz H ; Nallamothu, Brahmajee K ; Buckley, Christopher J ; Moody, Jonathan B ; Hagio, Tomoe ; Renaud, Jennifer M

PURPOSE:

Distinguishing obstructive epicardial coronary artery disease (CAD) from microvascular dysfunction and diffuse atherosclerosis would be of immense benefit clinically. However, quantitative measures of absolute myocardial blood flow (MBF) integrate the effects of focal epicardial stenosis, diffuse atherosclerosis, and microvascular dysfunction. In this study, MFR and relative perfusion quantification were combined to create integrated MFR (iMFR) which was evaluated using data from a large clinical registry and an international multi-center trial and validated against invasive coronary angiography (ICA).

METHODS:

This study included 1,044 clinical patients referred for ⁸²Rb rest/stress positron emission tomography myocardial perfusion imaging and ICA, along with 231 patients from the Flurpiridaz 301 trial (clinicaltrials.gov NCT01347710). MFR and relative perfusion quantification were combined to create an iMFR map. The incremental value of iMFR was evaluated for diagnosis of obstructive stenosis, adjusted for patient demographics and pre-test probability of CAD. Models for high-risk anatomy (left main or three-vessel disease) were also constructed.

RESULTS:

iMFR parameters of focally impaired perfusion resulted in best fitting diagnostic models. Receiver-operating characteristic analysis showed a slight improvement compared to standard quantitative perfusion approaches (AUC 0.824 vs. 0.809). Focally impaired perfusion was also associated with high-risk CAD anatomy (OR 1.40 for extent, and OR 2.40 for decreasing mean MFR). Diffusely impaired perfusion was associated with lower likelihood of obstructive CAD, and, in the absence of transient ischemic dilation (TID), with lower likelihood of high-risk CAD anatomy.

CONCLUSIONS:

Focally impaired perfusion extent derived from iMFR assessment is a powerful incremental predictor of obstructive CAD while diffusely impaired perfusion extent can help rule out obstructive and high-risk CAD in the absence of TID.

2023-10-01·Journal of the American College of Cardiology

Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease

Article

作者: Agostini, Denis ; Shepple, Benjamin ; Tamaki, Nagara ; Dorbala, Sharmila ; Garcia, Ernest V ; Berman, Daniel S ; Tranquart, Francois ; Bateman, Timothy M ; Martinez-Clark, Pedro ; Heller, Gary V ; Pelletier-Galarneau, Matthieu ; Beanlands, Rob S B ; Knuuti, Juhani M ; Maddahi, Jamshid ; Udelson, James E ; Bax, Jeroen J ; Feldman, James

BACKGROUND:

Flurpiridaz F-18 (flurpiridaz) is a novel positron emission tomography (PET) myocardial perfusion imaging tracer.

OBJECTIVES:

The purpose of this study was to further assess the diagnostic efficacy and safety of flurpiridaz for the detection and evaluation of coronary artery disease (CAD) defined as ≥50% stenosis by quantitative invasive coronary angiography (ICA).

METHODS:

In this second phase 3 prospective multicenter clinical study, 730 patients with suspected CAD from 48 clinical sites in the United States, Canada, and Europe were enrolled. Patients underwent 1-day rest/stress flurpiridaz PET and 1- or 2-day rest-stress Tc-99m-labeled single photon emission computed tomography (SPECT) before ICA. PET and SPECT images were read by 3 experts blinded to clinical and ICA data.

RESULTS:

A total of 578 patients (age 63.7 ± 9.5 years) were evaluable; 32.5% were women, 52.3% had body mass index ≥30 kg/m², and 33.6% had diabetes. Flurpiridaz PET met the efficacy endpoints of the study; its sensitivity and specificity were significantly higher than the prespecified threshold value by 2 of the 3 readers. The sensitivity of flurpiridaz PET was higher than SPECT (80.3% vs 68.7%; P = 0.0003) and its specificity was noninferior to SPECT (63.8% vs 61.7%; P = 0.0004). PET area under the receiver-operating characteristic curves were higher than SPECT in the overall population (0.80 vs 0.68; P < 0.001), women, and obese patients (P < 0.001 for both). Flurpiridaz PET was superior to SPECT (P < 0.001) for perfusion defect size/severity evaluation, image quality, diagnostic certainty, and radiation exposure. Flurpiridaz PET was safe and well tolerated.

CONCLUSIONS:

This second flurpiridaz PET myocardial perfusion imaging trial shows that flurpiridaz has utility as a new tracer for CAD detection, specifically in women and obese patients. (An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz [18F] Injection PET MPI in the Detection of Coronary Artery Disease [CAD]; NCT03354273).

2023-03-01·European journal of nuclear medicine and molecular imaging

Multi-center, multi-vendor validation of deep learning-based attenuation correction in SPECT MPI: data from the international flurpiridaz-301 trial

Article

作者: Poitrasson-Rivière, Alexis ; Buckley, Christopher ; Ficaro, Edward P ; Murthy, Venkatesh L ; Hagio, Tomoe ; Pierce, Lora ; Moody, Jonathan B ; Renaud, Jennifer M

PURPOSE:

Although SPECT myocardial perfusion imaging (MPI) is susceptible to artifacts from soft tissue attenuation, most scans are performed without attenuation correction. Deep learning-based attenuation corrected (DLAC) polar maps improved diagnostic accuracy for detection of coronary artery disease (CAD) beyond non-attenuation-corrected (NAC) polar maps in a large single center study. However, the generalizability of this approach to other institutions with different scanner models and protocols is uncertain. In this study, we evaluated the diagnostic performance of DLAC compared to NAC for detection of CAD as defined by invasive coronary angiography (ICA) in a large multi-center trial.

METHODS:

During the phase 3 flurpiridaz multi-center diagnostic clinical trial, conducted over 74 international sites, patients with known or suspected CAD who were referred for a clinically indicated ICA were enrolled. Using receiver operating characteristic (ROC) analysis, we evaluated the detectability of obstructive CAD, defined by quantitative coronary angiography by a core laboratory, using total perfusion deficit (TPD) as an integrated measure of defect extent and severity on DLAC polar maps compared to NAC polar maps. This was also compared against the visual scoring of three expert core lab readers.

RESULTS:

Out of 755 patients, 722 (69% male) had evaluable SPECT and ICA for this study. ROC analysis demonstrated significant improvement in detecting per-patient obstructive CAD with DLAC over NAC with area under the curve (AUC) of 0.752 (95% CI: 0.711-0.792) for DLAC compared to 0.717 (0.675-0.759) for NAC (p value = 0.016). Compared to the consensus of expert readers AUC = 0.743 (0.701-0.784), DLAC was comparable (p value = 0.913), whereas NAC underperformed (p value = 0.051).

CONCLUSION:

DL-based attenuation correction improves diagnostic performance of SPECT MPI for detecting CAD in data from a large multi-center clinical trial regardless of SPECT camera model or protocol.

TRIAL REGISTRATION:

A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD, ClinicalTrials.gov Identifier: NCT01347710, registered on 4 May 2011. https://clinicaltrials.gov/ct2/show/study/NCT01347710.

项与 Flurpiridaz F-18 相关的新闻（医药）

2024-02-07

·FierceBiotech

GE HealthCare plots theranostics growth as it beats earnings estimates in first solo year

“In the next three years, we plan to significantly increase our current theranostics franchise through a combination of organic and inorganic expansions,” GE HealthCare President and CEO Peter Arduini said on the company's fourth-quarter earnings call. In its first full 12 months as an independent, public company, GE HealthCare posted an 8% boost in organic annual revenue—but the company said it doesn’t expect that trajectory to continue into its sophomore year. The imaging giant has set its 2024 expectations at 4% organic sales growth. On a call with investors for the company’s fourth-quarter earnings report this week, Chief Financial Officer Jay Saccaro attributed last year’s gains to recovering supply chains and pricing advantages. “And a lot of that came down to execution, in terms of translating backlog into sales—which was a testament to the work by many of our teams. So, as we look to 2024, we think roughly 4% is a solid number,” said Saccaro, who also described 2023’s 8% figure as the high end of the company’s previous full-year predictions and “in excess of our expectations for the fourth quarter.” In terms of total revenue, GE HealthCare brought in $19.6 billion during 2023—including $10.6 billion from its CT and MRI imaging systems, $3.5 billion from ultrasound devices, $3.1 billion in patient care and monitoring solutions and $2.3 billion from pharmaceutical diagnostics. That last portfolio, with its nuclear medicine and cancer-targeting imaging tracers, grew 18% year-over-year and 23% in the fourth quarter, driven by global expansions in diagnostic procedures and their need for imaging agents. “As novel therapies become more widely available, our tracers will play an increasingly important role—putting us at the center of this transformation of care that will help enable better patient outcomes across many pathways as functional imaging expands,” President and CEO Peter Arduini said on the investor call. “We see growth opportunities with our existing products—like Vizamyl for patients with suspected Alzheimer’s disease, as new therapies ramp up—and Cerianna for metastatic breast cancer, which are both used in conjunction with PET systems for diagnosis,” Arduini added. “And Flurpiridaz, a pipeline product for diagnosing and assessing coronary artery disease, is expected to significantly advance PET/CT imaging.” These injectable imaging tools are also expected to help set the stage as patient care turns more toward theranostic procedures, blurring the lines between discrete tests and treatments. “To give you some perspective, currently the overall theranostics market—which includes equipment, tracers and therapies—is about $9 billion and expected to grow to $40 billion by 2032,” Arduini said. “Today, theranostics are primarily used in thyroid, neuroendocrine and prostate tumors. However, a growing pipeline of drugs across the industry that includes breast, ovarian, pancreatic and lung cancers shows even more promise.” “In the next three years, we plan to significantly increase our current theranostics franchise through a combination of organic and inorganic expansions,” he said, highlighting GE HealthCare’s recently proposed acquisition of the AI developer MIM Software and its plans to integrate the latter’s imaging analysis programs for radiation oncology, molecular radiotherapy, urology and theranostics in particular. GE HealthCare’s first year also saw the company pay down $1 billion in debt while putting more than $1 billion into its R&D spend and launching more than 40 new products. “As a result of our investments, we estimate that we have gained global market share in equipment in 2023. And, once again, we topped the FDA’s list of AI-enabled device authorizations with 58, more than any other medtech company,” Arduini said, referring to the agency’s accounting. “Our backlog remains robust, led by an improved capital equipment landscape.” For the fourth quarter of 2023, the company posted $5.2 billion in sales for a 5% gain over the same period the year before. Net income, however, dropped to $403 million from $554 million, while the accounting for the full year fell to $1.6 billion, compared to 2022’s $1.9 billion. All told, the price of GE HealthCare’s stock on the Nasdaq jumped more than 12% following its earnings release, to more than $81 per share. The company completed its split from the General Electric mothership in January 2023.

并购

2022-09-14

·NS Medical Devices

GE Healthcare and Lantheus Phase III Clinical Trial Finds flurpiridaz PET Radiotracer Could Improve Detection of Coronary Artery Disease

Phase III clinical trial of flurpiridaz PET diagnostic radiopharmaceutical meets co-primary endpoints for detecting Coronary Artery Disease (CAD) This radiotracer is part of GE Healthcare’s pipeline of Molecular Imaging diagnostics aiming to increase diagnostic accuracy and improve patient outcomes across key care areas. (Credit: Robina Weermeijer on Unsplash) GE Healthcare and Lantheus Holdings have announced that the recent Phase III clinical trial of their investigational radiotracer, flurpiridaz, has met its co-primary endpoints of exceeding a 60 percent threshold for both sensitivity and specificity for detecting Coronary Artery Disease (CAD). The findings, shared at the American Society of Nuclear Cardiology (ASNC) Congress, in Florida, U.S., also demonstrate flurpiridaz Positron Emission Tomography (PET) has higher diagnostic efficacy and image quality in patients with suspected CAD, compared with Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI), the predominant procedure used in nuclear cardiology today. SPECT MPI represents approximately 6 million procedures per year in the U.Si. The Phase III Open-Label Study, which involved over 600 patients across sites in the U.S., Europe and Canada assessed the diagnostic efficacy of flurpiridaz in detecting CAD, the most common form of heart diseaseii and the leading cause of death globallyiii, with invasive coronary angiography as a standard of truth. More than 120 million people are affected by CAD globally each yeariv and in the U.S. alone, approximately 20 million adults have CAD, with nearly 383,000 deaths recorded in 2020v. If approved, this investigational agent would offer the advantages of 18F, with broad available distribution and a half-life of almost two hours, removing the need for it to be manufactured in the immediate vicinity of the imaging department. This longer half-life could also make Flurpiridaz (18F) Injection suitable for exercise stress testing, which is not feasible with existing cardiac PET radiotracers. Dr. Tim Bateman, MD, FACC, co-director of the Cardiovascular Radiologic Imaging Program at Saint Luke’s Hospital, Missouri, US, shared: “These results are truly promising for the nuclear cardiology community and CAD patients. From ASNC’s inception, its leaders have laid out the specifications for an ideal myocardial perfusion tracer. In my view [18F]flurpiridaz could meet this goal, expanding how PET MPI can be used to image CAD patients moving forward.” Dr. Francois Tranquart, MD, PhD, Global Head of Clinical Development for GE Healthcare Pharmaceutical Diagnostics, Research and Development, said: “The positive Phase III trial results are a key step towards future approval of Flurpiridaz Injection as a potential new cardiac PET agent which could improve the detection of coronary artery disease. This is another example of GE Healthcare investing in our portfolio of Molecular Imaging products to help improve diagnostic accuracy and patient outcomes.” GE Healthcare has led the funding and development of flurpiridaz, and, if the imaging agent is approved, will have global commercialization rights. Lantheus has collaborated on the development and will also collaborate on potential commercialization through a joint steering committee. Lantheus is entitled to royalties based on commercial sales. GE Healthcare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patients every second. Its Molecular Imaging portfolio combines an innovative pipeline with established proprietary products across cardiology, neurology and oncology. Source: Company Press Release

合作

2022-09-13

·Mass Device

GE Healthcare, Lantheus radiotracer trial meets endpoints

The Phase III clinical trial for the Flurpiridaz radiotracer met its co-primary endpoints. It exceeded a 60% threshold for both sensitivity and specificity in detecting coronary artery disease (CAD). GE and Lantheus shared the results at the American Society of Nuclear Cardiology (ASNC) Congress, in Florida. According to a news release, the data also demonstrate higher diagnostic efficacy and image quality for the radiotracer. These data compared Flurpiridaz to single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI). The trial included over 600 patients across sites in the U.S., Europe and Canada. It assessed the diagnostic efficacy of Flurpiridaz in detecting CAD with invasive coronary angiography as a standard of truth. The companies said that, if approved, the investigational agent would offer broad available distribution and a half-life of almost two hours. That half-life removes the need for it to be manufactured in the immediate vicinity of the imaging department. It could also make it suitable for exercise stress testing, which is not currently feasible with existing cardiac PET radiotracers. “These results are truly promising for the nuclear cardiology community and CAD patients,” said Dr. Tim Bateman, co-director of the cardiovascular radiologic imaging program at Saint Luke’s Hospital, Missouri. “From ASNC’s inception, its leaders have laid out the specifications for an ideal myocardial perfusion tracer. In my view Flurpiridaz could meet this goal, expanding how PET MPI can be used to image CAD patients moving forward.” GE Healthcare leads the funding and development of Flurpiridaz. If it is approved, the company will hold global commercialization rights. Lantheus collaborated on the development and will collaborate on potential commercialization through a joint steering committee. It is entitled to royalties based on commercial sales. “The positive Phase III trial results are a key step towards future approval of Flurpiridaz injection as a potential new cardiac PET agent which could improve the detection of coronary artery disease,” said Dr. Francois Tranquart, global head of clinical development for GE Healthcare Pharmaceutical Diagnostics. This is another example of GE Healthcare investing in our portfolio of molecular imaging products to help improve diagnostic accuracy and patient outcomes.”

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100 项与 Flurpiridaz F-18 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
心血管疾病	临床3期	美国	GE Healthcare Ltd. (United Kingdom)	2022-01-30
心血管疾病	临床3期	美国	Progenics Pharmaceuticals, Inc.	2022-01-30
冠心病	临床3期	美国	Lantheus Medical Imaging, Inc.	2011-06-01
冠心病	临床3期	加拿大	Lantheus Medical Imaging, Inc.	2011-06-01
冠心病	临床3期	芬兰	Lantheus Medical Imaging, Inc.	2011-06-01
冠心病	临床3期	波多黎各	Lantheus Medical Imaging, Inc.	2011-06-01
缺血	临床2期	美国	Lantheus Medical Imaging, Inc.	2009-01-01
肿瘤	临床1期	德国	Bayer AG	2009-04-01

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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


ESC2023	临床3期	冠心病	730	Flurpiridaz PET	簾鏇衊窪憲齋蓋衊糧襯(鬱遞鏇築鬱構憲憲網築) = 淵簾遞夢窪鹽構夢蓋積構選範獵繭衊顧淵淵淵 (壓鑰範製築壓餘製鏇遞 )	-	2023-08-27
				flurpiridaz F-18	簾鏇衊窪憲齋蓋衊糧襯(鬱遞鏇築鬱構憲憲網築) = 窪鹽廠觸積憲窪鹽蓋膚構選範獵繭衊顧淵淵淵 (壓鑰範製築壓餘製鏇遞 )
NCT04594941 (CTgov)	临床2期	冠心病	38	Flurpiridaz (18F) (Flurpiridaz (18F): SPE)	鑰憲範醖壓選齋遞憲蓋(觸夢淵製壓網願襯範窪): Least Sqaure (LS) Mean Difference = -0.149 (90.0% CI, -1.431 ~ 1.133), P-Value = 0.8452; LS Mean Difference = -0.015 (90.0% CI, -1.899 ~ 1.868), P-Value = 0.9890; LS Mean Difference = -0.753 (90.0% CI, -2.204 ~ 0.698), P-Value = 0.3852; LS Mean Difference = -0.091 (90.0% CI, -1.735 ~ 1.554), P-Value = 0.9260 更多	-	2023-08-01
				Flurpiridaz (18F) (Flurpiridaz (18F): HPLC)
NCT03354273 (CTgov)	临床3期	冠心病	730	Flurpiridaz (18F) (Flurpiridaz (18F))	糧鹹遞製廠醖夢網壓鬱(範鏇壓鹹觸廠窪鬱膚憲) = 獵憲襯鹽艱蓋餘鏇齋觸夢廠鬱製憲齋糧築願衊 (壓繭壓簾範簾鹽顧鑰鑰, 願衊繭憲夢觸壓鏇鹹淵 ~ 餘衊膚鹽範簾餘鏇艱淵) 更多	-	2023-07-12
				Flurpiridaz (18F) (Flurpiridaz (18F) PET MPI)	糧鹹遞製廠醖夢網壓鬱(鹽窪蓋窪蓋網範選獵衊) = 糧醖憲鬱壓築範網製選襯繭獵鹽齋鑰選鑰構窪 (廠構鑰鏇夢襯醖衊淵廠, 鹽壓憲鬱觸繭襯餘憲襯 ~ 積築糧鹹顧廠選繭構醖) 更多
NCT01347710 (Pubmed \| J Am Coll Cardiol) 人工标引	临床3期	冠心病	755	Fluorine-18 Flurpiridaz (PET)	獵淵齋襯襯鹹觸簾鏇餘(壓選膚遞壓觸構餘網膚) = 窪襯膚蓋遞願艱範淵窪衊糧顧選襯遞顧窪願製 (淵淵簾願獵齋艱衊廠鑰, 0.4) 更多	积极	2020-07-28
				Fluorine-18 Flurpiridaz (SPECT)	獵淵齋襯襯鹹觸簾鏇餘(壓選膚遞壓觸構餘網膚) = 衊鏇築簾艱衊艱夢觸築衊糧顧選襯遞顧窪願製 (淵淵簾願獵齋艱衊廠鑰, 3.2 ) 更多
NCT01347710 (CTgov)	临床3期	冠心病	795	Flurpiridaz F18 (Flurpiridaz F18 PET MPI)	夢繭鹹窪鏇廠積憲鑰鏇(鹽糧糧獵鏇製衊鏇構簾) = 蓋觸構齋顧衊淵醖壓襯壓醖夢鏇廠憲積衊繭襯 (衊壓觸遞鑰憲繭鬱範廠, 淵鏇憲繭鏇製窪憲選餘 ~ 廠鹹獵製鹽製艱廠築鬱) 更多	-	2016-04-05
				Flurpiridaz F (Flurpiridaz F 18)	夢鹹簾積餘鹽鹹餘餘築(鏇遞夢壓蓋獵積鏇鹽襯) = 積鹽醖襯獵鬱憲襯衊遞醖簾艱齋艱窪鹹憲製鹹 (壓餘範糧獵鬱鹽繭範構, 憲窪糧襯鏇窪獵網餘願 ~ 鏇膚膚廠廠窪遞遞鬱壓) 更多
NCT00849108 (CTgov)	临床2期	缺血	176	BMS747158	襯選鏇齋廠選選淵餘願(淵淵餘衊廠簾遞淵淵艱) = 觸夢鏇鬱窪鑰簾鏇鬱蓋齋遞鹽獵糧顧觸淵膚膚 (鹽簾簾鑰糧遞餘夢獵願, 網顧衊獵範壓網顧鏇獵 ~ 鬱襯醖鹹夢鹽壓築觸膚) 更多	-	2015-01-19