what is therasphere treatment

The cost-effectiveness of TheraSphere in patients with determined that TheraSphere is the most appropriate treatment for your . Two types of beads can be used for this treatment: SIR-Spheres are approved by the Food and Drug Administration (FDA) for people with tumors in the liver that have spread from colon cancer. . News release. Management and Treatment How is liver cancer treated? TheraSphere typically is an outpatient procedure. Therasphere. These beads are injected (put) into the main artery that brings blood to the liver. TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. TheraSphere treatment does not require hospitalization and is usually performed as an outpatient procedure within an hour. As background, I have breast cancer that metastisized to my lungs and liver. Second-line systemic treatment in mCRC can prolong survival after development of disease progression during or after first-line treatment and in those who are . They are glass microspheres and a typical dose involves administration of 5-8 million microspheres. TheraSphere treatment can generally be administered on an outpatient basis and does not usually require an overnight hospital stay. Anti-hormone treatments stopped working. Again, thanks for the kind words and wisdom! Sometimes TheraSphere can be a bridge to surgery or transplant, Kennedy said. The applicant must submit the information required by 10 CFR 30.33 and 35.12, as described below. Today they did a "test run" on me. Yttrium-90 was associated with acceptable OS with minimal morbidity in this series. Minimal exposure to chemotherapy and low HBD were found to be associated with better OS, however, even patients with chemotherapy-refractory disease received a benefit from treatment. Per estimates, HCC is one of the most . Yttrium-90 microspheres (TheraSphere and SIR-Spheres) for the treatment of unresectable hepatocellular carcinoma Issues Emerg Health Technol. Treatment with TheraSphere has been optimized to minimize unnecessary radiation exposure through the packaging of the dose vial, use of the Administration Accessory Kit and the radiation dose delivery mechanism. TheraSphere is an intraarterial therapy used primarily for the treatment of patients with HCC. 5, 2013 -- Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services for the prevention, diagnosis and treatment of disease, announced today that it has launched a new and improved, intuitive, feature-rich TheraSphere . The approval is based on findings from the retrospective LEGACY trial, in which TheraSphere, a personalized radiotherapeutic cancer treatment, elicited an overall response rate of 72.2% at 4 weeks per blinded independent central review (BICR) as neoadjuvant or . 1 The approval is based on findings from the retrospective . The standard of treatment for a GBM is surgery, followed by daily radiation and oral chemotherapy for six and a half weeks, then a six-month regimen of oral chemotherapy given five days a month. You can go back to your everyday activities 1 day after your treatment. I have been on Nexavar for 2 1/2 years for lung mets from my liver cancer, it has worn out its welcome . TheraSphere is a radiation treatment for people who have a specific type of liver cancer called unresectable hepatocellular carcinoma (HCC). This study presents hepatic toxicity results after unilobar and bilobar intra-arterial administration of 90 Y-S in patients with unresectable HCC who had . I had therasphere treatment to my primary liver cancer tumor in april of 2012. death occurred 173 days after initiation of TheraSphere and 66 days after the last dose of TheraSphere. This dose will be verified by Medical Physics. 90Y-Microspheres .SIR-Spheres TheraSphere Resin-based spheres.Glass spheres.Radiomicrospheres Purpose The purpose of this guideline is to assist nuclear medicine specialists in: 1. TheraSphere is a radiotherapy treatment for hepatocellular carcinoma (HCC) that consists of millions of microscopic, radioactive glass microspheres (20-30 micrometres in diameter) being infused into the arteries that feed liver tumors. In the morning, the 61-year-old Hudson, Wisconsin, resident visited his doctor and underwent a . Dose Range: A Y-90 TheraSpheres treatment is intended to expose the liver to 80 to 150 Gy. Radioembolization is very similar to chemoembolization but using radioactive microspheres instead of chemotherapy drugs. The FDA has approved TheraSphere yttrium-90 (Y-90) glass microspheres for the treatment of patients with unresectable hepatocellular carcinoma (HCC). TheraSphere treatment is a selective internal radiation therapy (SIRT) that involves specific delivery of microscopic glass beads carrying radioactive yttrium (Y-90) to target tumours through a catheter. The cancer community has seen an increase in the number of liver cancer diagnoses over the past decade. Per estimates, HCC is one of the most . The result is a powerful, targeted and well-tolerated therapy that may lead to patients . TheraSphere is now the only radioembolization technology indicated for the treatment of unresectable HCC in the U.S. [IMG] HCC is one of the most prevalent cancers in the world and the most common . Modifying Therasphere Treatment for Inoperable Liver Cancer. The beads get trapped in the tumor and small blood vessels that bring blood to the liver tumor (s). In the trial, TheraSphere treatment - a selective internal radiation therapy (SIRT) comprised of microscopic glass beads containing radioactive yttrium (Y-90) that are specifically delivered to . Y90 is most commonly used during a radioembolization therapy, an internal radiation therapy. To start, the neurosurgeon will remove as much of the tumor as possible and may implant medicated wafers right into the brain. "Something that we take pride in is to be able to offer this treatment for patients, so that it is convenient for them and they don't have to drive hours away," said Dr. Frederick Johnson. During this time, doctors will insert TheraSphere directly into your tumor . The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. 2007 Sep;(102):1-6. The spheres kill cancer cells both by irradiation and by cutting off the blood supply to the tumor. TheraSphere is a treatment for liver cancer that prolongs life for patients who cannot undergo liver surgery (resection), and for whom standard chemotherapy is not appropriate, or has not been effective.. TheraSphere delivers radiation directly to tumors in the liver using millions of tiny beads. Prior to that, I had a liver biopsy (where they inadvertently punctured my lung), a "mapping" procedure, and then the actual therasphere treatment. When Y-90 is incorporated into very tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels supplying the liver. Conclusions This study indicates that treatment with TheraSphere is a potentially cost-effective option for patients with early to intermediate stage HCC. Mark Turnbull dismissed the discomfort and figured it would go away by morning, but the pain only intensified as the evening went on. The IR physician and Radiation Oncologist prescribe the amount of Y-90 TheraSpheres using the Y-90 TheraSpheres Written Directive. For more information on TheraSphere, visit www.therasphere.com. The Y90 treatment is delivered though the vein exactly like an angiogram. Significance of the Approval. angiography). TheraSphere and SIR-Spheres use tiny microspheres to deliver radiation therapy directly into the liver. Radioembolization is also known as selective internal radiation therapy. Significance of the Approval. The second, Therasphere (MDS Nordion, Toronto, Canada), is not fully FDA-approved but has a humanitarian device exemption (HDE) for the treatment of hepatocellular carcinoma (HCC). TheraSphere Now is a cloud-based website designed to facilitate TheraSphere treatment order submission, tracking and order management. June 2011 #9. Author C Allison. TheraSphere is a targeted liver cancer therapy with low toxicity, consisting of millions of tiny glass beads containing radioactive Yttium-90. TheraSphere.com provides unique resources and targeted information about this innovative radioembolization therapy OTTAWA, Ontario--(BUSINESS WIRE)--Mar. The objective of this study was to compare the efficacy of these two devices in treatment of patients (pts) with unresectable hepatocellular carcinoma (HCC). Up to approximately 70% of patients with metastatic colorectal cancer (mCRC) have metastases to the liver at initial diagnosis. Please explain TheraSphere's mechanism of action. The prescribed dose should correspond to the doses provided by MDS . These include your general health, how well your liver is working, the stage of the cancer that you have and your levels of alpha-fetoprotein. This means it gives off radiation. And, although the treatment is considered palliative rather than curative, the therapy buys time for patients until they are able to receive an alternate therapy or become eligible for surgery or liver transplant. An HUD is a device that has been approved Dose Range: A Y-90 TheraSpheres treatment is intended to expose the liver to 80 to 150 Gy. 29-Nov-2001 12:00 AM EST, by University of Maryland Medical Center contact patient services. By Will Warlick, MD, radiation oncologist. TheraSphere.com provides unique resources and targeted information about this innovative radioembolization therapy OTTAWA, Ontario--(BUSINESS WIRE)--Mar. The glass beads (20-20 micrometers in diameter - about a third of the width of a human hair) are delivered directly to the liver tumors. In the trial, TheraSphere treatment - a selective internal radiation therapy (SIRT) comprised of microscopic glass beads containing radioactive yttrium (Y-90) that are specifically delivered to . TheraSphere&reg has HDE approval from the FDA for the treatment of hepatocellular cancer (HCC) for use in "radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of . One(0.6%) fatal adverse event occurred in patients who received TheraSphere:cerebral vascular accident; the. TheraSphere, 100% reimbursed by Medicare and many commercial health insurers, is used to treat patients with unresectable hepatocellular carcinoma (HCC) and can be used as a bridge to surgery or transplantation in . Your doctor has. Yttrium-90 (Y90) is a commonly used isotope within the nuclear medicine and radiation oncology communities for radiation therapy. PURPOSE: Intra-arterial injection of Yttrium-90 glass microspheres ( 90 Y-S; TheraSphere, MDS Nordion, Ottawa, Canada) is indicated for treatment of unresectable hepatocellular carcinoma (HCC) in the presence of acceptable liver function. A sharp pain in his side woke him from a sound sleep one night. The addition of TheraSphere treatment significantly increased both PFS (p=0.0013) and hPFS (p<0.0001). 1 Previously, TheraSphere Y-90 microsphere were used through an FDA humanitarian device exemption classification, which limited the number of patients able to be treated with this form of selective internal radiation therapy per year. PMID: 17824141 Abstract (1) Microspheres containing radioactive yttrium-90 (90Y) are infused into the hepatic artery. About TheraSphere TheraSphere [90] Y glass microspheres are specifically engineered to carry far greater power than any other [90] Y liver-directed cancer therapy, delivering high doses of radiation to liver tumours while sparing normal tissue. Mean sphere diameter 20-30 m Y-90 -Pure beta emitter -Decays to stable zirconium-90 -Physical half life of 64.2 hours (2.68 days) -Average energy of beta emissions is 0.94 MeV Don't exercise or do any heavy lifting (more than 10 pounds or 4.5 kilograms) for the next 3 days. Cleveland Clinic is also evaluating another particle type, TheraSphere , in which are small glass spheres made radioactive in a nuclear reactor, for hepatocellular and colorectal cancers. It killed my tumor and I have had no reoccurance in my liver. Y90 18 Months ago I had the Y90 treatment in Chicago. The prescribed dose should correspond to the doses provided by MDS . Evaluating patients who might be candidates for treatment using intra-arterial radioactive compounds for primary or secondary liver cancer 2. The company stated that TheraSphere treatment, a type of selective internal radiation therapy (SIRT) with low toxicity, is comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90) that are delivered directly to liver tumors via a catheter and result in minimal exposure to surrounding healthy tissue. Radioembolization is the use of radioactive microspheres to embolize the vessels feeding a liver tumor. This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies. TheraSphere treatment, indicated for use in patients with hepatic neoplasia/malignancies including liver dominant mCRC in Canada, Europe and regions of Asia, delivers Y-90 directly to liver tumors via catheter, which minimizes radiation exposure to surrounding healthy tissue. Now, Cleveland Clinic is participating in study of the value of radioembolization earlier in the treatment cycle, in conjunction with second-line chemotherapy. These internal radiation therapies use the tumor's blood supply to deliver the treatment directly into the tumor, while reducing damage to nearby healthy tissue. Endpoints Provide TheraSphere for patients who it is determined by their treating physicians and/or tumor board that the device is appropriate for the treatment of unresectable HCC in accordance with the FDA recommendation of use of a HUD within its approved indication or for the treatment of the patient's other primary or secondary liver . Patients receiving TheraSphere treatment with second-line chemotherapy were 31% less likely to show disease progression or death (HR= 0.69) and 41% less likely to show hepatic disease progression or death versus with chemotherapy alone (HR= 0.59). The applicant should submit additional Most of these can be attributed to prior hepatitis infections, cirrhosis or fatty liver infiltration. Yttrium-90 (Y-90) is a radioactive substance. The therasphere treatment is only available in Vancouver BC, and Montreal Que, and I'm not sure if it is even covered by our health care system. o MDS Nordion manufactures glass microspheres called TheraSphere&reg. If you have liver cancer, your treatment and chance of recovery (also called prognosis) may depend on certain things. 30 days . Reference: Boston Scientific Receives FDA Approval for TheraSphere Y-90 Glass Microspheres. About this study. In prescribing TheraSphere as a treatment, your doctor has taken into consideration several factors such as liver performance status, medical history, previous therapy and the liver blood flow to minimize side effects and optimize While this procedure has wide acceptance and even payment by the . Planning celiac and hepatic angiography to define the TheraSphere is approved as a humanitarian use device (HUD) to treat hepatocellular carcinoma. Treatment - You will be in the procedure for one to two hours. This therapy is used to treat both primary and metastatic liver tumors. TheraSphere, which was approved by the U.S. Food and Drug Administration earlier this month, is the only radioembolization technology in the U.S. indicated for the treatment of unresectable HCC. In our institutions, patients are carefully evaluated, often incorporating multidisciplinary evaluation from medical oncology, surgical oncology, radiation oncology, transplant surgery, hepatology, and interventional radiology. It is indicated for patients with hepatic neoplasia/malignancies, including mCRC of the liver, in Canada, Europe and Asian regions. TheraSphere treatment involves a four-step process: Pre-planning angiogram - Enables your doctor to determine if you are a suitable candidate for TheraSphere. TheraSphere treatment is commonly referred to as selective . 0. dandickinson33 Member Posts: 2. In the TheraSphere cohort, 87% more patients were predicted to achieve downstaging compared to all other treatment options. Significance of the Approval. Modifying Therasphere Treatment for Inoperable Liver Cancer. At Cancer Treatment Centers of America (CTCA), our liver cancer treatments include chemotherapy, radiation therapy, surgery, interventional radiology, gastroenterology procedures and targeted therapy.You may also be a candidate for immunotherapy.A multidisciplinary team of liver cancer treatment experts will answer your questions and recommend treatment options based on your unique . Radioembolization is very similar to chemoembolization but using radioactive microspheres instead of chemotherapy drugs. TheraSphere TheraSphere consists of yttrium-90 (Y-90) as an integral constituent of insoluble glass microspheres. BSC assesses this event as not related to the TheraSphere treatment and pre-treatment imaging procedures. Radioembolization treatment is a two-stage outpatient process: the preparation/mapping stage and the treatment stage. Three Therasphere specific tests are also preformed before treatment, they are: CT-scan of chest and abdomen, with algorithm for calculation of the volume of each liver lobe, which is necessary for determine the dose of Theraspheres to be given. "Third, quality of life is maintained after TheraSphere, an outcome in cancer therapy that is extremely important when patients are ultimately selecting a treatment. I had the Therasphere treatment done 4 weeks ago. I believe that theraspheres are for primary liver cancer and sir spheres are for mets to the liver. TheraSphere treatment does not require hospitalization and is usually performed as an outpatient procedure within an hour. Notably, treatment with TheraSphere does not require hospitalization and is typically an outpatient process and this benefit may potentially alleviate pressure on the current health care system. Second, TheraSphere, a treatment for HCC that can be done as an outpatient procedure, is very well tolerated," lead author Dr. Riad Salem said in prepared remarks. TheraSphere therapy provides an alternative treatment to those patients not eligible for surgery. 224 Objectives There are 2 commercially available devices Y-90 SIR-Spheres (Resin microsphere, SIRTex) and TheraSphere (glass microsphere, MDS Nordion) for treatment of unresectable hepatic tumors. This dose will be verified by Medical Physics. Tags: Liver, Organ Donation, TheraSphere, Transplant Orientation, Y-90. TheraSphere is suitable for patients in whom either the liver is the only site of disease or the liver is the major site of disease. TheraSphere treatment is commonly referred to as selective internal radiation therapy (SIRT), transarterial radioembolization (TARE), or simply radioembolization. 5, 2013 -- Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services for the prevention, diagnosis and treatment of disease, announced today that it has launched a new and improved, intuitive, feature-rich TheraSphere . How does TheraSphere . Therasphere is a minimally invasive outpatient procedure and patients can typically resume daily activities within 24 to 48 hours. This therapy is used to treat both primary and metastatic liver tumors. The FDA has approved TheraSphere Yttrium-90 (Y-90) Glass Microsphere for the treatment of patients with hepatocellular carcinoma.1. I had a single lesion about 2.8 cm. The FDA has approved TheraSphere Yttrium-90 (Y-90) Glass Microspheres for the treatment of patients with hepatocellular carcinoma. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere. The treatment is effective, Gordon said, but it is more painful and can hurt future treatment options. Background: Colorectal cancer is one of the most common cancers and causes of cancer-related death. Patient thankful Y90 treatment slows liver cancer. Once you go home, you can be in a room with friends and family. disease. The purpose of this protocol is to provide supervised and limited access to Therasphere treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. These microspheres then embolize, lodging themselves in the liver's capillaries and bathing the malignancy in high levels of yttrium-90 radiation. The beads, which measure one third the diameter of a human hair, contain a radioactive element . license for the use of TheraSphere and SIR-Spheres and is not intended to be the only means of satisfying the requirements for a license. This treatment involves injection of plastic or glass microspheres incorporating the radioactive isotope Yttrium-90 directly into the tumor. TheraSphere is used to treat malignant tumors in the liver. The docs need to "map" the road thought the veins in order to get to the tumor so they can inject the beads. Categories: MEDICAL. When used for the treatment, Y90 is relied upon to provide a prescribed amount of radiation to a targeted area. This treatment involves injection of plastic or glass microspheres incorporating the radioactive isotope Yttrium-90 directly into the tumor. Per estimates, HCC is one of the most . TheraSphere radiation treatment for liver cancer. TheraSphere is suitable for patients in whom either the liver is the only site of disease or the liver is the major site of disease. The IR physician and Radiation Oncologist prescribe the amount of Y-90 TheraSpheres using the Y-90 TheraSpheres Written Directive. Chantal . It is attached to tiny beads that are smaller than a human hair. It consists of millions of microscopic glass spheres . TheraSphere treatment does not require hospitalization and is usually performed as an outpatient procedure within an hour. 29-Nov-2001 12:00 AM EST, by University of Maryland Medical Center contact patient services. Treatment with TheraSphere has been optimized to minimize unnecessary radiation exposure through the packaging of the dose vial, use of the Administration Accessory Kit and the radiation dose delivery mechanism. What happens after TheraSphere treatment? About Boston Scientific Worn out its welcome are for primary liver cancer called unresectable hepatocellular carcinoma in treatment And radiation Oncologist prescribe the amount of radiation to a targeted area to. 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