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]

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

NCT05620771 / RecruitingPhase 2IIT

Phase II Study Therasphere® (Yttrium-90) in Combination With Systemic Therapy in Patients With High-risk Hepatocellular Carcinoma

The purpose of this research is to compare progression free survival between two available systemic therapies - immunotherapy and tyrosine kinase inhibitors - after Therasphere® (yttrium-90) treatment in adult patients with advanced hepatocellular carcinoma. The immunotherapy consists of a standard-of-care treatment with Atezolizumab and Bevacizumab. Treatment with tyrosine kinase inhibitors consists of standard-of-care Lenvatinib or Cabozantinib.

Start Date30 Nov 2022

Sponsor / Collaborator

Northwestern University

[+1]

100 Clinical Results associated with Yttrium 90

100 Translational Medicine associated with Yttrium 90

100 Patents (Medical) associated with Yttrium 90

1,098

Literatures (Medical) associated with Yttrium 90

01 Dec 2024·American journal of ophthalmology case reports

Yttrium-90 (90Y) brachytherapy for squamous carcinoma: Treatment of the conjunctiva, cornea, and sclera

Article

Author: Finger, Paul T ; Maniar, Arpita ; Materin, Miguel A. ; Chino, Junzo ; Meltsner, Sheridan ; Materin, Miguel A ; Finger, Paul T.

Purpose:

Patients with conjunctival squamous cell carcinoma that present with persisting disease or recurrence following topical chemotherapy and/or surgery especially when invading the sclera are challenging to treat. Herein, we describe the use of high-dose-rate (HDR), FDA-cleared, yttrium-90 (⁹⁰Y) plaque brachytherapy for such lesions.

Observation:

Three cases of invasive conjunctival squamous cell carcinoma that had exhibited a poor response or recurrence following topical chemotherapy and/or surgery are described. As treatment, HDR ⁹⁰Y beta-radiation was applied to the tumor and margins for a single, continuous duration. In contrast to low-dose-rate (LDR) plaque, HDR ⁹⁰Y brachytherapy did not require episcleral sutures, amniotic membrane buffering of the cornea, a Gunderson flap, outpatient dwell time, or second surgery. Radiation safety was improved by eliminating LDR-implant related post-operative radiation exposure to health care personnel, the community, family, and pets. Follow-up examination at one month revealed complete tumor resolution in all patients. At last follow-up (8, 11 and 18 months) all patients remained clinically tumor-free as confirmed by slit-lamp biomicroscopy, anterior segment optical coherence tomography, and high-frequency ultrasound imaging. There were no acute complications (e.g., corneal edema, iridocyclitis, scleropathy, keratopathy or cataract).

Conclusion and Importance:

⁹⁰Y brachytherapy demonstrated efficacy as a single-surgery, minimally invasive, outpatient irradiation for squamous carcinoma of the ocular surface. While short-term results were promising, long-term follow-up monitoring for side-effects and recurrence are essential.

01 Nov 2024·JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY

Combining Radioembolization and Immune Checkpoint Inhibitors for the Treatment of Hepatocellular Carcinoma: The Quest for Synergy

Review

Author: Hickey, Ryan ; Krishnan, Sunil ; Sarwar, Ammar ; He, Aiwu ; Mody, Kabir ; Bajaj, Suryansh ; Malone, Christopher D ; Patel, Tushar ; Toskich, Beau ; Malone, Christopher D.

Hepatocellular carcinoma (HCC) is a leading and increasing contributor to cancer-related death worldwide. Recent advancements in both liver-directed therapies in the form of Y-90 radioembolization (Y-90-RE) and systemic therapy in the form of immune checkpoint inhibitors (ICI) have expanded treatment options for patients with an otherwise poor prognosis. Despite these gains, ICIs and Y-90-RE each have key limitations with low objective response rates and persistent hazard of out-of-field recurrence, respectively, and overall survival remains low. However, each therapy's strength can mitigate the other's weakness, making them ideal partners for combination treatment strategies. This review discusses the scientific and clinical rationale for combining Y-90-RE with ICIs, highlights early clinical trial data on its safety and efficacy, and proposes key issues to be addressed in this emerging field. With optimal strategies, combination therapies can potentially result in durable and curative outcomes in later stage patients rarely achieved just a decade ago.

01 Nov 2024·CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY

Systemic Immunological Changes After Yttrium-90 Radioembolization: A Pilot Prospective Observational Study—Clinical Insights

Article

Author: Sofocleous, Constantinos T. ; Sofocleous, Constantinos T ; Petre, Elena N ; Dimopoulos, Platon M ; Kitsel, Yuliya ; Vakiani, Efsevia ; Ganesh, Karuna ; Dimopoulos, Platon M. ; Wong, Phillip ; Petre, Elena N. ; Sotirchos, Vlasios ; Rousseau, Benoit

PURPOSE:

To prospectively investigate levels of circulating cytokines, changes in frequencies of various immune cell subsets and expression of proliferation and checkpoint molecules on T cells in the peripheral blood after yttrium-90 radioembolization (TARE) of colorectal cancer liver metastases (CLM).

MATERIALS AND METHODS:

We prospectively collected, isolated, and froze peripheral blood mononuclear cells (PBMC) and plasma samples from 15 patients immediately before, immediately after, 3 and 6 weeks post-TARE of CLM. Plasma samples were assessed for various cytokines using a multiplex immunoassay platform. PBMC samples were analyzed in a monocyte/dendritic cell (DC)/B cell flow panel and a T cell activation/exhaustion flow phenotyping panel. We compared the levels at the respective time points using Wilcoxon signed rank test.

RESULTS:

IFN-g significantly decreased immediately after (mean 1.62 vs. 3.02 at baseline, p = 0.04) and increased at 6 weeks compared to the immediately post-TARE nadir (mean 9.42 vs. 1.62, p = 0.04). IL-10 decreased at 3 weeks (mean 0.36 vs. 1.75, p = 0.025) post-TARE compared to baseline. Increased CD3⁺T cells (mean 78.24 vs. 60.8, p = 0.002) and decreased CTLA-4⁺CD4⁺T cells (mean 2.58 vs. 4.41, p = 0.033) were observed at 3 weeks compared to baseline. Increased Ki-67⁺ proliferating CD8⁺T cells at 3 and 6 weeks (mean 7.28 and 9.06, respectively, vs. 3.93 at baseline, p = 0.02 and 0.03) were recorded.

CONCLUSION:

A shift toward a favorable antitumoral cytokinic and immune cells response was observed after TARE. Significant changes were in specialized immune cells subsets playing important roles in the activation of the immune system. These results support trials combining TARE with immunotherapy for patients with CLM.

News (Medical) associated with Yttrium 90

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

05 Aug 2024

·www.prnewswire.com

Sirtex Medical Launches SIR-Spheres® FLEXdose SELECT Delivery Program to Enable More Selective Y-90 Treatment Plans

Sirtex announces SIR-Spheres® portfolio expansion to include the FLEXdose SELECT 3mL vial configuration allowing for more patient-specific Y-90 selective treatment plans WOBURN, Mass., Aug. 5, 2024 /PRNewswire/ -- Sirtex Medical ("Sirtex"), a leading manufacturer of interventional treatment solutions, announced today the launch of its SIR-Spheres® FLEXdose SELECT Delivery Program, an innovative, new way to offer precise Y-90 selective internal radiation therapy for the treatment of metastatic colorectal cancer. SIR-Spheres® FLEXdose SELECT Delivery Program offers unparalleled flexibility by enabling tailored, patient-specific dosing from a single 3mL delivery vial. This program also marks the availability of 3mL SIR-Spheres® vials, which contain a reduced volume of microspheres (approximately 27 million compared to 44 million in the current 5mL vials). With up to five days pre-calibration available every day of the week, the novel Y-90 delivery program offers a vial of SIR-Spheres® designed for more selective treatment targeting. "We're pleased to introduce this latest innovation in Y-90 radioembolization therapy to treat a broader spectrum of tumor burden," said Matt Schmidt, CEO of Sirtex Medical Limited. "The SIR-Spheres® FLEXdose SELECT Delivery Program reflects our continued focus on listening to the needs of patients and physicians by enabling access to personalized Y-90 resin doses and expedited patient treatments." "I have found the SIR-Spheres® FLEXdose Program to be extremely helpful in treating my patients on a timely basis," explained Ripal Gandhi, M.D., a member of the Miami Cardiac & Vascular Institute and Miami Cancer Institute and the course director for the Symposium on Clinical Interventional Oncology. "With this program, I can personalize the Y-90 treatment for each of my patients using a product that is available every day of the week. I applaud Sirtex for investing resources in SIR-Spheres® FLEXdose SELECT and providing more options for physicians to optimize treatment strategies for even more patients." The new 3mL SIR-Spheres® Y-90 resin microspheres vials are available for order at [email protected]. For more information and details on how to incorporate the SIR-Spheres® FLEXdose SELECT Delivery Program into your practice, please contact Sirtex at [email protected]. About SIR-Spheres SIR-Spheres® are a medical device used in selective internal radiation therapy). SIR-Spheres® are indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine). Caution: Federal (USA) law restricts this device for sale by or on the order of a physician. Consult the Instructions for Use () for a complete listing of indications, contraindications, side effects, warnings and precautions. About Sirtex Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex's current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. For more information, visit . SOURCE Sirtex Medical Inc.

Radiation Therapy

100 Deals associated with Yttrium 90

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diagnostic agents	EU	CIS Bio International SA	24 Mar 2003
Diagnostic agents	IS	CIS Bio International SA	24 Mar 2003
Diagnostic agents	LI	CIS Bio International SA	24 Mar 2003
Diagnostic agents	NO	CIS Bio International SA	24 Mar 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	Phase 3	CN	ClinChoice Medical (TIANJIN) Co., Ltd.	13 Sep 2021
Hepatocellular Carcinoma	Phase 3	CN	Biocompatibles UK Ltd.	13 Sep 2021
Carcinoid Tumor	Phase 2	PL	Uniwersytet Warminsko Mazurski	02 Nov 2004
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 2	PL	Uniwersytet Warminsko Mazurski	02 Nov 2004
Neuroendocrine Tumors	Phase 2	PL	Uniwersytet Warminsko Mazurski	02 Nov 2004
Pheochromocytoma	Phase 2	PL	Uniwersytet Warminsko Mazurski	02 Nov 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EASL_LCS2024	Not Applicable	Hepatocellular Carcinoma	150	resin 90Y	qnjognyzrq(rjuzlrsiwj) = typjanwdgm rshielfmbs (tvaijqxqpf ) View more	Positive	22 Feb 2024
				resin 90Y	qnjognyzrq(rjuzlrsiwj) = nfpzcxcnbw rshielfmbs (tvaijqxqpf ) View more
ASTRO	Not Applicable	Melanoma	-	Yttrium-90 (90Y) (iWand AÂ® applicator)	ojhpbpxcei(ybgqcnyfej) = putytjgcnp vvpyaximxi (yxhetsppny ) View more	-	01 Nov 2022
SNMMI2022	Not Applicable	-	-	Y-90 (Y90 SIR-Spheres)	fuexwoueop(kqwkyrrmgv) = wuxqhcomef munetjzqfs (tynrewfayx )	-	08 Aug 2022
				Y-90 (TheraSphere)	fuexwoueop(kqwkyrrmgv) = qfxqahzftw munetjzqfs (tynrewfayx )
SNMMI2022	Not Applicable	Hepatocellular Carcinoma	-	Yttrium-90 (90Y-glass radioembolization)	vfnjveiuef(pbidwqzknd) = kuyrsagiev jimbpcifgm (rrtmnsrdgs )	-	08 Aug 2022
SNMMI2021	Not Applicable	Liver metastases	35	yttrium 90 (Patients with metastatic liver disease)	ykxsoltoae(pxdwnufvyl) = fchbyzghol auviwpqtld (ngeebapjpm, 4.9 (IQR 3.9 - 7.1)) View more	Positive	18 May 2021
SNMMI2020	Not Applicable	-	5	Y-90 (CFDose predicted dose distribution)	urifktmwpr(dhrkeqkgcj) = jcsufhpmtp lduekpanbg (rvxixcbclm )	-	15 May 2020
ASTRO	Not Applicable	Liver Cancer	-	Yttrium-90 (Tc-99m MAA SPECT/CT)	ztdshyknyi(iseusdctrd) = wcrevczinm xlronxsgzk (avxbwcuvui, 3.2) View more	-	01 Sep 2019
				Yttrium-90 (Planar gamma camera scintigraphy (PS))	ztdshyknyi(iseusdctrd) = pivzandbeu xlronxsgzk (avxbwcuvui, 4.5) View more
ASCO2019	Not Applicable	Liver metastases	77	Y90 radioembolization (G1 tumors)	chcyjwbbkq(dinmvcmfra) = yhvkalrcyb ndhcxsutul (ivramhjrrt )	Positive	26 May 2019
				Y90 radioembolization (G2 tumors)	chcyjwbbkq(dinmvcmfra) = bdanydzjrc ndhcxsutul (ivramhjrrt )
ASCO2019	Not Applicable	Colorectal Liver Metastases	58	Y90 radioembolization following failure of first line of chemotherapy	cmkilhrsrc(kehkdbcrbm) = cuypdbvymf bbarwyvlwq (nkkvfakgrt )	Positive	26 May 2019
				Y90 radioembolization following multiple lines of chemotherapy	cmkilhrsrc(kehkdbcrbm) = bwqluyvshc bbarwyvlwq (nkkvfakgrt )
ASCO2018	Not Applicable	Neuroendocrine Tumors	47	Y-90 radioembolization	bplfpylkxz(utnqkczwhe) = grade 3 abdominal pain (6%) eyxqllfema (pdzniitnvr ) View more	Positive	01 Jun 2018

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