BACKGROUNDRegional lymph node metastasis is the strongest prognostic factor in patients with melanoma. Published reports that used lymphoscintigraphy with radioactive colloids and blue dye demonstrated accurate sentinel lymph node (SLN) identification in inguinal nodes and axillary nodes, but decreased accuracy in cervical, popliteal, epitrochlear, and parascapular nodes. Near-infrared imaging (NIR) may utilize indocyanine green (ICG) to improve SLN identification. The safety, feasibility and optimal dose of albumin-bound ICG (ICG:HSA) was assessed by NIR to improve SLN mapping in patients with melanoma.METHODSTwenty-five consecutive patients with biopsy-proven melanoma underwent standard SLN mapping with preoperatively administered technetium-99 m nanocolloid (Tc-99 m). Intraoperative NIR fluorescence imaging was performed after injection of 1.0 ml of 100, 250 or 500 μM of ICG:HSA in four quadrants around the primary lesion.RESULTSNIR fluorescent imaging demonstrated accuracy of 98 % when compared with radioactive colloid. A total of 65 lymph nodes were identified (65 with Tc-99 m, 64 with ICG:HSA). Overall, successful mapping that used either technique was 96 % as one patient failed to map with either modality. As the dose of ICG was increased, the signal-to-background ratio increased from a median of 3.1 to 8.4 to 10.9 over the range of 100, 250, and 500 μM, respectively.CONCLUSIONSSLN mapping with ICG:HSA is feasible and accurate in melanoma. ICG has the added advantage of a low cost and an intraoperative technique that does not alter the surgical field, thus allowing for easy identification of SLNs.

2012-08-01·Rheumatology2区 · 医学

Evaluation of Chronic Kidney Disease Epidemiology Collaboration equation to estimate glomerular filtration rate in scleroderma patients

2区 · 医学

Article

作者: Antonietta Gigante ; Biagio Barbano ; Rosario Cianci ; Carmelina Rossi ; Felice Salsano ; Ilenia Molinaro ; Antonio Amoroso ; Edoardo Rosato ; Rita Massa

OBJECTIVERenal involvement in SSc is often subclinical and chronic kidney disease (CKD) develops, with slow worsening of glomerular filtration rate (GFR). The present investigation was undertaken in order to study how well the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) correlates with measured GFR (mGFR) in a group of SSc patients with serum creatinine (sCr) in the normal range.METHODSForty-one scleroderma patients (37 females and 4 males) with a median age of 46 years were enrolled. GFR was measured using technetium-99 m DTPA (Tc-99 m DTPA). The modified Cockroft-Gault formula, 4- and 7-variable Modification of Diet in Renal Disease (MDRD) and CKD-EPI equations were used for estimated GFR (eGFR).RESULTSmGFR showed a median value of 84 ml/min (range 32.8-121.2 ml/min). Seven patients had reduced GFR (<60 ml/min), 19 had GFR within 60-90 ml/min and 15 had GFR >90 ml/min. The results showed mild correlation between the BSA-modified Cockroft-Gault and mGFR (P > 0.05), mild statistically significant correlation with 4-variable MDRD (P < 0.05), high statistically significant correlation with 7-variable MDRD (P = 0.01), but the greatest correlation was obtained using CKD-EPI (P = 0.002). No correlation with age, disease duration or subset of disease was found.CONCLUSIONSIn scleroderma patients with normal sCr value, CKD-EPI is a useful formula to assess GFR.

2004-12-01·Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences

[Measurement of glomerular filtration rate with renal dynamic imaging: comparison with two-sample method].

Article

作者: Wang, Yan-fu ; Cui, Ying ; Li, Qian ; Wang, Rong-fu ; Zhang, Chun-li ; Zhao, Guang-yu ; Guo, Feng-qin ; Zuo, Li ; Zhou, Yu-hong ; Zhang, Xu-chu

OBJECTIVETo compare the estimation of glomerular filtration rate (GFR) by renal dynamic imaging with that estimated by two-sample method and evaluate the reliability of measurement of GFR by renal dynamic imaging.METHODSThe study was performed in 54 patients (33 males and 21 females; aged 15 to 82 years) with primary or secondary chronic nephrosis. The patients were intravenously bolus injected with 185 MBq /1mL of (99)Tc(m)-DTPA 20 min after drinking 300 mL of water. Renal dynamic imaging was performed and the image was processed according to standard procedure (Gates' method) to obtain GFR. 3 mL of blood was withdrawn 2 h and 4 h postinjection, respectively, and radioactivity of 1mL plasma was measured. GFR was calculated by the formula of two-sample method. The correlation of GFRs measured by renal dynamic imaging and by two-sample method was analyzed using regression analysis. The correlations of GFRs determined by the two methods with urea and creatinine were also measured.RESULTSThe GFR measured by renal dynamic imaging was slightly lower than that measured by two-sample method. Excellent correlation was obtained by two methods with r= 0.881 5 and P<0.01. The linear regression equation was GFR (renal dynamic imaging method)=0.661 4GFR (two-sample method) +21.89. The related lines of GFRs measured by the two methods with urea or creatinine were similar, which indicated the two methods were similar in identifying the changes in renal function. GFRs measured by the two methods showed good agreement for most of patients except three patients who were too thin or too fat.CONCLUSIONGenerally, GFR obtained by renal dynamic imaging is reliable for identifying the changes in renal function and correlated well with GFR obtained by two-sample method. But great error may be obtained with specific individuals, such as too thin or too fat subjects.

项与 Technetium Tc-99m red blood cells (CURIUM) 相关的新闻（医药）

2023-08-15

·GlobeNewswire-Health Care

Curium Announces Achievement of Co-Primary Endpoints in Phase 2 of Its Phase 1/2 SOLAR Clinical Trial Imaging Men With Histologically-Proven Prostate Cancer Using Copper Cu 64 PSMA I&T

PARIS, Aug. 15, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the positive results of the multi-center, open-label, Phase 2 SOLAR study of Copper Cu 64 PSMA I&T in patients with histologically-proven metastatic prostate cancer. The study has met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate. The purpose of this study was to evaluate the safety, biodistribution, and image quality of Copper Cu 64 PSMA I&T to detect metastatic prostate cancer using PET/CT imaging. The SOLAR Phase 2 study was conducted in the U.S. and included a group of 26 patients with metastatic prostate cancer. Michael Patterson, CEO – North America at Curium, commented, “The milestone announced today demonstrates Curium’s global commitment to driving innovations in prostate cancer diagnosis and treatment, and is extremely encouraging for prostate cancer patients. Our proven ability to reliably manufacture and distribute Cu-64 diagnostic agents throughout the U.S. means that we are well positioned for the upcoming Phase 3 trials to ultimately improve the lives of patients.” Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium, commented, “We are very pleased to report that our Copper Cu 64 PSMA I&T product for PET/CT imaging in the detection of recurrent prostate cancer has met the co-primary endpoints. Consistent with our mission to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are encouraged by the readouts of the SOLAR Phase 2 clinical trial. Our goal is to accelerate the Copper Cu 64 PSMA I&T Phase 3 clinical development and move forward with pivotal Phase 3 clinical trials in biochemical recurrence and initial staging setting in metastatic prostate cancer in early 2024.” Prostate cancer is the second most common cancer after skin cancer among men in the United States. There will be an estimated 288,000 new cases of prostate cancer in 2023. For more information about the SOLAR trial: https://www.curiumpharma.com/resources/current-clinical-trials/solar-clinical-trial/ To contact Curium’s SOLAR clinical trial team: solar@curiumpharma.com About Curium Curium 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

临床结果临床2期

2023-07-25

·GlobeNewswire-Health Care

Curium Announces License and Development Agreement With Lantheus for AI-Based PSMA PET Software in Europe

Builds on existing collaboration between Curium and Lantheus for prostate cancer PSMA-targeted PET imagingDeep-learning platform for standardization of comprehensive reporting in Europe PARIS, July 25, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today a ‘License and Development’ agreement with EXINI Diagnostics AB, a Lantheus company (EXINI), to customize EXINI’s artificial intelligence (AI) platform for use in Europe. The agreement builds on the existing prostate cancer PSMA-targeted PET imaging collaboration between Curium and Lantheus with an exclusive licensing and development agreement for AI-powered quantitative analysis and standardized reporting of PSMA PET/CT image assessments. Today’s announcement follows the May 2023 decision by the Committee for Medicinal Products for Human Use of the European Medicines Agency that recommended granting a marketing authorization for PYLCLARI® (piflufolastat (18F)), intended for the diagnosis of prostate cancer. Under the terms of the agreement, EXINI’s deep learning platform will be tailored to meet the specific needs of the European market. The clinical value proposition of the platform is to increase the efficiency and reproducibility of PSMA PET/CT image assessments in prostate cancer and establish the standard for comprehensive reporting across the US and Europe. The deep learning algorithm will be trained on anonymized data from Curium’s European Phase III PYTHON (NCT04734184) clinical trial, in addition to the existing dataset from the two U.S. registrational studies (OSPREY - NCT02981368 and CONDOR - NCT03739684) of piflufolastat F18. The AI-enabled assessment will assist in bringing increased consistency, reliability, and efficiency in reporting PSMA-avid total disease burden and in monitoring its change with treatments. Benoit Woessmer, CEO PET Europe at Curium commented: “By leveraging artificial intelligence and the extensive anonymized data from our European PYTHON clinical trial, this is an important milestone in enhancing prostate cancer diagnosis, and indeed for the patients themselves. We are excited about using deep learning to help us redefine the experience of cancer through our trusted legacy in nuclear medicine.” Etienne Montagut, Chief Business Officer at Lantheus commented: “PSMA PET has had an important impact on prostate cancer management. With the expanding treatment options in prostate cancer, including PSMA RLT, there is increasing demand for efficient, standardized quantitative assessment of PSMA disease burden. Our partnership with Curium expands the pool of patient data informing our AI algorithm and enables more widespread access to our software.” About Curium Curium 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 curiumpharma.com. For more information: Ross BethellVP, Head of Global Communicationcommunications@curiumpharma.com

引进/卖出临床3期上市批准

2023-05-26

·GlobeNewswire-Health Care

Curium Receives Positive CHMP Opinion of PYLCLARI® for Primary Staging of Patients With High-Risk PCa Prior to Initial Curative Therapy and to Localize Recurrence of PCa in Patients With a Suspected Recurrence Based on Increasing Serum Prostate-Specific Antigen (PSA) Levels After Primary Treatment With Curative Intent

If approved for Europe, PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) will offer prostate cancer patients access to a diagnostic imaging agent more sensitive than conventional imaging.Proven track record of [18F]-DCFPyL (branded as PYLARIFY® in the U.S.), with more than 100,000 prostate cancer patient scans performed in 2022 in the U.S. PARIS, May 26, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) for primary staging of patients with high-risk PCa prior to initial curative therapy and to localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent. Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, “This positive CHMP opinion for PYLCLARI® is an important step forward in our goal of redefining the experience of cancer through our trusted legacy in nuclear medicine. We are extremely pleased with the CHMP positive opinion and recommendation to grant a marketing authorization in Europe for PYLCLARI®, a diagnostic imaging medicine for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults 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.” Benoit Woessmer, PET Europe CEO at Curium added, “This CHMP positive opinion is a very important milestone for Curium, our customers, and their patients. Upon its approval, PYLCLARI® will become available across Europe to help patients along their prostate cancer journey. We are very excited to bring PYLCLARI® to the market and contribute to improving the set of diagnostic tools available to better diagnose and monitor prostate cancer. PSMA PET with PYLARIFY® is the standard of care in the U.S. We are looking forward to answering the high expectations of the nuclear medicine community when it comes to having the right tool reliably available to address this fast-growing pathology.” Curium submitted its Marketing Authorization Application for Piflufolastat (18F) to the EMA in July 2022. The CHMP’s positive opinion on PYLCLARI® will be referred to the European Commission, which will deliver a final decision in approximately two months. In the U.S., [18F]-DCFPyL was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY® (Piflufolastat F 18 Injection) and sold by Lantheus. In 2022, more than 100,000 patient scans using PSMA PET with PYLARIFY were performed. 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

上市批准临床3期

100 项与 Technetium Tc-99m red blood cells (CURIUM) 相关的药物交易

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