A Phase II Pilot Study of yttriuM-90 in Combination With capEcitabine and aTezolizumab for oligomEtastatic cOlorectal Cancer With unResectable lIver MeTastasEs (METEORITE)

BrUOG-430 is a prospective, single-arm, phase 2 trial evaluating yttrium-90 radioembolization in combination with capecitabine and atezolizumab for the treatment of unresectable colorectal cancer liver metastases in individuals who have been treated with two or more lines of systemic therapy.

Start Date30 Dec 2024

Sponsor / Collaborator

Brown University

[+2]

NCT06725121

/ RecruitingPhase 1/2IIT

Downstaging of Hepatocellular Carcinoma with Macrovascular Invasion by Radiotherapy (SBRT or Y90) and Atezolizumab Plus Bevacizumab Followed by Liver Transplantation - a Prospective Trial

The goal of this clinical trial is to learn if locoregional therapy and immunotherapy can be used together to help patients with hepatocellular carcinoma (HCC) and macrovascular invasion achieve liver transplantation.
The main questions it aims to answer are:
* How many patients will achieve transplant with this treatment strategy?
* What will the 5-year survival and recurrence-free survival rates be for these patients?
Participants will:
* Undergo a biopsy of the tumor.
* Receive locoregional therapy (SBRT or Y90) followed by immunotherapy (atezolizumab and bevacizumab) 2 to 6 weeks later, for a maximum of 9 months.
* Be referred for a liver transplant and undergo the procedure if deemed eligible and safe.
* If applicable, be followed for five years post-transplant with regular data collection.

Start Date01 Dec 2024

Sponsor / Collaborator

University Health Network

NCT05692037

/ RecruitingPhase 1/2IIT

Yttrium-90 Carbon Microspheres in Patients With Unresectable Colorectal Liver Metastases: A Multicentre, Prospective, Open-label, Single-arm Trial

To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable colorectal liver metastases

Start Date28 Dec 2022

Sponsor / Collaborator

Southeast University Affiliated Zhonda Hospital

100 Clinical Results associated with Yttrium 90

100 Translational Medicine associated with Yttrium 90

100 Patents (Medical) associated with Yttrium 90

1,150

Literatures (Medical) associated with Yttrium 90

01 Mar 2025·Applied Radiation and Isotopes

Multi-dose formulation and clinical deployment of [90Y]Y-labeled hydroxyapatite (HA) microparticles for radiation synovectomy in India– the inherent intricacies

Article

Author: Patra, Sourav ; Vimalnath, K V ; Kamaleshwaran, K K ; Chakraborty, Sudipta ; Rajeswari, A

The present article describes intricate details involved in the formulation and quality control of 113 ready to use doses of [⁹⁰Y]Y-labeled hydroxyapatite (HA) microparticles for clinical use in radiation synovectomy using ⁹⁰Y produced by (n,γ) route. Yttrium-90 was produced with a specific activity of 720 ± 95 MBq/mg of Y and radionuclidic purity of >99.9%. Optimized protocol developed for one-step formulation of [⁹⁰Y]Y-HA microparticles was adopted to prepare the clinical doses (400 ± 50 MBq ⁹⁰Y in each dose) in 20 batches. The radiochemical purity of the product was >99.0% in all 20 batches and all other quality control parameters were as per the monogram approved for its clinical use in India. More than 100 patients suffering from inflammatory joint diseases of mainly knee joints were treated with doses of [⁹⁰Y]Y-HA microparticles. Clinical investigations post-treatment demonstrated the effectiveness of the formulation in the management of the disease.

01 Mar 2025·Applied Radiation and Isotopes

Bayesian multiple linear regression method for simultaneous determination of Cherenkov counting efficiencies of 89Sr, 90Sr and 90Y from mixed standard including 89Sr and 90Sr

Article

Author: Park, Jieun ; Sohn, Wook

In this study, Bayesian linear regression was employed to simultaneously determine Cherenkov counting efficiencies for ⁸⁹Sr, ⁹⁰Sr, and ⁹⁰Y from a mixed standard. Among the two codes utilized, PyMC3 and Stan, the latter produced more reliable posterior distributions for the three efficiencies, particularly for ⁹⁰Sr which is challenging to estimate due to its minimal activity changes. Validation showed excellent agreement between the activities determined with Stan's estimates and the certified activities, implying the applicability of the Bayesian approach.

01 Jan 2025·Journal of Vascular and Interventional Radiology

Safety and Effectiveness of Yttrium-90 Radioembolization in People Living with HIV

Article

Author: Gottlieb, Ricki A ; Bishay, Vivian ; Garcia-Reyes, Kirema ; Menon, Kartikeya M ; Kim, Edward ; Patel, Rahul ; Zhang, Jack ; Marron, Thomas

PURPOSETo investigate if Yttrium-90 radioembolization (Y90 TARE) is a safe and effective treatment in people living with HIV (PLWH) with hepatocellular carcinoma (HCC) across the BCLC stage spectrum.MATERIALS AND METHODSA retrospective review was conducted of all patients with HCC presented at a multidisciplinary institutional liver tumor board who underwent Y90 TARE between January 2014 and June 2023. Thirty-nine patients with documented HIV seropositivity prior to Y90 TARE and adherence to HAART were included. For 19 (48.7%) patients, CD4 and total lymphocyte counts and HIV viral load PCR data were collected before and after Y90 TARE within 12 weeks of therapy. Kaplan-Meier analysis was used to compute median overall survival (OS) and the Fine-Gray sub-distribution hazard model was used to estimate progression-free survival (PFS). Imaging response was assessed by mRECIST and adverse events were analyzed per CTCAE version 5.0.RESULTSFor the 19 patients with HIV laboratory data available, the mean CD4 lymphocyte count dropped from 374.3 +/- 238.9 cells/mm³ to 180.3 +/- 144.3 cells/mm³ (p<0.001) after Y90 TARE but rebounded to 320.9 +/- 234.3 cells/mm³ at 12-month follow up (p=0.01). The overall response rate (ORR) was 87.2% and the disease control rate (DCR) was 97.4%. Median OS was 35.8 months (95% CI 17.0 months to no estimate [NE]) and median PFS was 14.7 months (95% CI 10.7-28.9 months). There were no grade 3 clinical toxicities, 3 grade 3 biochemical toxicities and 1 opportunistic infection 18 months following Y90 TARE were reported.CONCLUSIONY90 TARE is safe and effective in PLWH with HCC. No significant HIV-related adverse events were attributable to radioembolization.

News (Medical) associated with Yttrium 90

22 Nov 2024

·pipelinereview.com

First Patient Treated in Phase I/II Trial in Acute Myeloid and Acute Lymphoblastic Leukemia with Lu177-PentixaTher, Expanding the Evidence Base for Targeted Radiotherapy Approach

BERLIN and WURZBURG, Germany I November 21, 2024 I Pentixapharm Holding AG, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, today announced that the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of Lu177-PentixaTher, a novel radiopharmaceutical therapy, in adults for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial, funded by the French Ministry of Health and led by a renowned investigator team from the University Hospital in Nantes, represents a significant step toward expanding targeted radiotherapy options for hematologic malignancies. The investor-initiated study, named PENTILULA (ClinicalTrials.gov ID: NCT06356922) is a multicenter, open-label trial in which up to 21 patients with relapsed/refractory AML or ALL will be enrolled over a period of 24 months, with a total study duration of 36 months. The primary objective is to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher, and to examine key efficacy parameters such as overall response rate (ORR) and complete remission (CR) after infusion of the novel radiotherapeutic agent. Following a peer-reviewed publication in January 2023 in the prestigious Journal of Nuclear Medicine highlighting promising clinical results in the treatment of patients suffering from T-cell lymphoma, further evidence continues to be built up about the potential of Pentixapharm’s lead candidate, PentixaTher, for the treatment of haemato-oncological diseases. The study is significant for Pentixapharm insofar as the incidence of ALL and AML, and hence the medical need, is much higher than that for T-Cell lymphoma. The PENTILULA trial is the first trial that combines PentixaTher with Lutetium-177, a radioisotope widely and successfully used for the treatment of castration resistant prostate cancer or neuroendocrine tumors. Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are aggressive and life-threatening blood cancers that affect thousands of people worldwide each year. AML is the most common type of acute leukemia in adults, with an incidence of approximately 20,000 new cases per year and low five-year survival rate of 31.9% in the United States [1]. ALL is the most common type of cancer in children, with a high incidence in adults as well. Current treatment options often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. Effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient. “Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes. We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies,” explains Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm. “We are delighted that leading experts such as Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes have decided to initiate this study to evaluate this novel radiotherapeutic treatment option. We are committed to providing our full support, leveraging our therapeutic knowledge with PentixaTher and facilitating access to the compound to drive this important research forward.” Professor Françoise Kraeber-Bodéré is the Head of the department of Nuclear Medicine at the University Hospital in Nantes, France, and an expert of the Oncology committee of the French Society of Nuclear Medicine (SFMN) as well as of the Oncology and Therapy committee of the European Association of Nuclear Medicine. She is on the scientific board of the French Lymphoma research group LYSA and expert for PET imaging in lymphoma and myeloma. Professor Patrice Chevallier is a specialist in Hematology and member of the executive committee and scientific council of HéMA, an umbrella organization for hemato-oncological research in Western France. About Pentixapharm Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases. Its Pipeline includes PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68 based companion diagnostic for blood cancers and cardiovascular diseases. PentixaTher is an innovative radiotherapeutic that specifically targets the chemokine-4 receptor (CXCR4). Background material about its potential for the treatment of haematooncological diseases can be found at: About Nantes University Hospital Nantes University Hospital (CHU de Nantes) is one of France’s leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting thousands of clinical trials and contributing to significant advancements in healthcare. [1] https://seer.cancer.gov/statfacts/html/amyl.html SOURCE: Pentixapharm

Clinical Study

21 Nov 2024

·www.globenewswire.com

First Patient Treated in Phase I/II Trial in Acute Myeloid and Acute Lymphoblastic Leukemia with Lu177-PentixaTher, Expanding the Evidence Base for Targeted Radiotherapy Approach

BERLIN and WURZBURG, Germany, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Pentixapharm Holding AG, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, today announced that the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of Lu177-PentixaTher, a novel radiopharmaceutical therapy, in adults for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial, funded by the French Ministry of Health and led by a renowned investigator team from the University Hospital in Nantes, represents a significant step toward expanding targeted radiotherapy options for hematologic malignancies. The investor-initiated study, named PENTILULA (ClinicalTrials.gov ID: NCT06356922) is a multicenter, open-label trial in which up to 21 patients with relapsed/refractory AML or ALL will be enrolled over a period of 24 months, with a total study duration of 36 months. The primary objective is to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher, and to examine key efficacy parameters such as overall response rate (ORR) and complete remission (CR) after infusion of the novel radiotherapeutic agent. Following a peer-reviewed publication in January 2023 in the prestigious Journal of Nuclear Medicine highlighting promising clinical results in the treatment of patients suffering from T-cell lymphoma, further evidence continues to be built up about the potential of Pentixapharm’s lead candidate, PentixaTher, for the treatment of haemato-oncological diseases. The study is significant for Pentixapharm insofar as the incidence of ALL and AML, and hence the medical need, is much higher than that for T-Cell lymphoma. The PENTILULA trial is the first trial that combines PentixaTher with Lutetium-177, a radioisotope widely and successfully used for the treatment of castration resistant prostate cancer or neuroendocrine tumors. Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are aggressive and life-threatening blood cancers that affect thousands of people worldwide each year. AML is the most common type of acute leukemia in adults, with an incidence of approximately 20,000 new cases per year and low five-year survival rate of 31.9% in the United States [1]. ALL is the most common type of cancer in children, with a high incidence in adults as well. Current treatment options often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. Effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient. “Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes. We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies,” explains Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm. “We are delighted that leading experts such as Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes have decided to initiate this study to evaluate this novel radiotherapeutic treatment option. We are committed to providing our full support, leveraging our therapeutic knowledge with PentixaTher and facilitating access to the compound to drive this important research forward.” Professor Françoise Kraeber-Bodéré is the Head of the department of Nuclear Medicine at the University Hospital in Nantes, France, and an expert of the Oncology committee of the French Society of Nuclear Medicine (SFMN) as well as of the Oncology and Therapy committee of the European Association of Nuclear Medicine. She is on the scientific board of the French Lymphoma research group LYSA and expert for PET imaging in lymphoma and myeloma. Professor Patrice Chevallier is a specialist in Hematology and member of the executive committee and scientific council of HéMA, an umbrella organization for hemato-oncological research in Western France. About Pentixapharm Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases. Its Pipeline includes PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68 based companion diagnostic for blood cancers and cardiovascular diseases. PentixaTher is an innovative radiotherapeutic that specifically targets the chemokine-4 receptor (CXCR4). Background material about its potential for the treatment of haematooncological diseases can be found at: https://edoc.mdc-berlin.de/id/eprint/24012/1/24012oa.pdf About Nantes University Hospital Nantes University Hospital (CHU de Nantes) is one of France's leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting thousands of clinical trials and contributing to significant advancements in healthcare. For more information, please contact: Pentixapharm Holding AGPhillip Eckert, Investor Relationsir@pentixapharm.comTel. +49 30 94893232www.pentixapharm.com [1] https://seer.cancer.gov/statfacts/html/amyl.html

Clinical Study

16 Sep 2024

·www.prnewswire.com

Sirtex Medical Announces Certification of SIR-Spheres® Y-90 Resin Microspheres According to Medical Device Regulation (EU) 2017/745 and European Launch of the Innovative SIROS™ Delivery System

Sirtex brings an innovative liver cancer treatment delivery system to Europe, enhancing options for physicians and their patients. WOBURN, Mass., Sept. 16, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, today announced that it has received certification according to Medical Device Regulation (EU) 2017/745 for SIR-Spheres® Y-90 resin microspheres and its delivery systems, paving the way for the European launch of the SIROS™ Delivery System. The EU MDR places greater emphasis on patient safety measures, risk management, post-market surveillance, and comprehensive data collection for medical devices seeking European market access. "Patient health and safety are always at the forefront of our work. That is why we are particularly proud to receive EU MDR certification for SIR-Spheres® Y-90 resin microspheres and its delivery systems, including SIROS™. This achievement underscores our commitment to delivering innovative products responsibly and ethically," said Matt Schmidt, CEO of Sirtex Medical Inc. "With the expansion of SIROS™ outside of the U.S., interventional radiologists in Europe now have an additional option to support patients battling metastatic colorectal cancer (mCRC) and unresectable hepatocellular carcinoma (HCC). This milestone reflects the outstanding efforts of our team, the rapid growth of our business, and the groundbreaking interventional oncology solutions we have developed." The SIROS™ Delivery System offers an intuitive, visual, and adaptable solution for physicians to administer SIR-Spheres® to liver cancer patients. Its easy-to-use design along with controlled administration provides physicians confidence in the Y-90 delivery. "As an interventional radiologist, I am excited about the future use of the SIROS™ Delivery System," shared Professor Thomas Helmberger, Head of Department of Radiology, Neuroradiology, and Minimal-Invasive Therapy at München Klinik Bogenhausen in Munich, Germany. "This device has an intuitive design and a precise control that will facilitate the administration of SIR-Spheres® Y-90 resin microspheres, and I am looking forward to incorporating it into my practice." About SIR-Spheres® in Europe SIR-Spheres® are medical devices used in selective internal radiation therapy (SIRT) and are indicated for the treatment of unresectable hepatocellular carcinoma (HCC) and unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy. For a complete listing of indications, contraindications, side effects, warnings, and precautions, please consult the Instructions for Use at . About Sirtex Sirtex is a global healthcare company with offices in the U.S., Australia, Europe, and Asia, dedicated to improving patients' quality of life and longevity through innovative, minimally invasive cancer and embolization therapies. Sirtex's current leading product, SIR-Spheres® Y-90 resin microspheres, offers targeted radiation therapy for liver cancer. For more information, visit . SOURCE Sirtex Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Radiation Therapy

100 Deals associated with Yttrium 90

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	V09	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diagnostic agents	LI	Eckert & Ziegler Radiopharma GmbH	19 Jan 2006
Diagnostic agents	NO	Eckert & Ziegler Radiopharma GmbH	19 Jan 2006
Diagnostic agents	IS	Eckert & Ziegler Radiopharma GmbH	19 Jan 2006
Diagnostic agents	EU	Eckert & Ziegler Radiopharma GmbH	19 Jan 2006

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	Phase 3	CN	Biocompatibles UK Ltd.	13 Sep 2021
Hepatocellular Carcinoma	Phase 3	CN	ClinChoice Medical (TIANJIN) Co., Ltd.	13 Sep 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_ASIA2024	Not Applicable	Unresectable Hepatocellular Carcinoma	63	Yttrium-90 (Y-90) resin microspheres (SIRT with Y-90 resin microspheres)	yefflulsdi(axsaczwyio) = developed in 8 (12.7%) patients and no serious AE was reported btkpdfdcmc (iddggjkzqa ) View more	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	Unresectable Hepatocellular Carcinoma	63	Yttrium-90 (Y-90) resin microspheres (SIRT with Y-90 resin microspheres)	qgwpqkmmyx(ikxtwpberp) = developed in 8 (12.7%) patients and no serious AE was reported cyprmbwsgy (whptbxjciu ) View more	Positive	07 Dec 2024
SNMMI2023	Not Applicable	-	-	13C-Methacetin Breath Tyttrium-90 (Radioembolization with yttrium-90-loaded resin microspheres)	gnnroncjoj(bjzhpmzaip) = significant increase after 7 days mxxpujlrey (qvlzvcgmvw ) View more	-	28 Aug 2023
ASTRO2022	Not Applicable	Melanoma	-	Yttrium-90 (90Y) (iWand AÂ® applicator)	cbnjkoavod(qwxmmfuzxe) = kkeuyvvhjb cntttdvcty (mralzgmbus ) View more	-	01 Nov 2022
TARGET Round Robin sub-study (EANM2022)	Not Applicable	Hepatocellular Carcinoma 90 Y glass microspheres	20	Yttrium-90 (Anatomic workflow)	mefdbpcwfp(hhjnbgglif) = jwcywzhwbm txkdhkrzea (gsqzbxctro ) View more	-	22 Sep 2022
TARGET Round Robin sub-study (EANM2022)	Not Applicable	Hepatocellular Carcinoma 90 Y glass microspheres	20	Yttrium-9099m Tc-MAA (99m Tc-MAA SPECT workflow)	mefdbpcwfp(hhjnbgglif) = ehjqbgvkhq txkdhkrzea (gsqzbxctro ) View more	-	22 Sep 2022
SNMMI2022	Not Applicable	Hepatocellular Carcinoma	-	Yttrium-90 (90Y-glass radioembolization)	(avthigymyv) = snvmllrgii nnzpkvvyco (kryghsbprl )	-	08 Aug 2022
SNMMI2022	Not Applicable	-	-	Y-90 (Y90 SIR-Spheres)	kfavcoztuh(rjvyutzfzw) = pofcjvnqcf dfsyuodmjp (gtajjtdclr )	-	08 Aug 2022
SNMMI2022	Not Applicable	-	-	Y-90 (TheraSphere)	kfavcoztuh(rjvyutzfzw) = gdcadnbojt dfsyuodmjp (gtajjtdclr )	-	08 Aug 2022
SNMMI2021	Not Applicable	Liver metastases	35	yttrium 90 (Patients with metastatic liver disease)	dxrfmysngl(fsrxtqqehl) = tlsbrqjobm zmfroxkbeb (fcqemcniml, 4.9 (IQR 3.9 - 7.1)) View more	Positive	18 May 2021
EANM2020	Not Applicable	-	-	Yttrium-90 (SiPM-based PET/CT)	ekvjcmspit(mzsdqgklgs) = kbndrmzbmy kskbaadsnq (lnddxslurg ) View more	-	18 Sep 2020
EANM2020	Not Applicable	-	-	yttrium-90 (Plastic syringe shield)	ygcfeevzdr(wzuvjvhjhy) = ibkhaevdyu jagdxovbtm (oxquertrqw ) View more	-	18 Sep 2020
EANM2020	Not Applicable	-	-	yttrium-90 (High energy tungsten syringe shield)	ygcfeevzdr(wzuvjvhjhy) = mkcmryzhho jagdxovbtm (oxquertrqw ) View more	-	18 Sep 2020

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