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Torch Dosimetry Software Platform as a Complete Y90 Transarterial Radioembolization Planning and Dosimetry Tool (Exhibit Hall D - Science Pavilion (Convention Center); In-Person Only) - May 8, 2024 - Abstract #SNMMI2024SNMMI_2086; Given the high quantitative accuracy of dose calibrators and challenges associated with accurate 90Y-PET/CT quantification, LDMKA is the preferred algorithm for accurate 90Y-PET/CT-based dosimetry following 90Y-RE. Typically, only Medical Internal Radiation Dose (MIRD)
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Trial completion, Enrollment change, Trial initiation date: TACOME: Transarterial Radioembolization (TARE) in COlorectal MEtastasis of Liver (clinicaltrials.gov) - Apr 24, 2024 P=N/A, N=202, Completed, MIDOS offers evaluation of treatment outcomes, such as TNR and LSF, and quantitative scenario-specific decisions. Not yet recruiting --> Completed | N=350 --> 202 | Initiation date: Sep 2023 --> Jan 2024
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Modified radiation lobectomy (MRL) in the treatment of intrahepatic cholangiocarcinoma (ICC) as a bridge to surgery: a case report () - Apr 10, 2024 - Abstract #ECIO2024ECIO_402; The patient underwent a radioembolization procedure known as MRL, by using the modified (segmental+lobar) approach that included segmental posterior right lobe treatment (segments 6-7) followed by right-whole-lobe treatment. This intervention is doubled aimed by trying to reduce tumor size and to produce hypertrophy of the left lobe, in order to perform surgery with sufficient FLR.The radiation dose was 257Gy to segments 6-7 and 99Gy to the right-hepatic-lobe, (total tumor dose 484Gy) with 90-Y-glass-microspheres (TheraSphere
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Treatment of intrahepatic cholangiocarcinoma with Y-90 glass microspheres in the PROACTIF study (Auditorium 2) - Apr 10, 2024 - Abstract #ECIO2024ECIO_165; Patients received personalized treatment (multicompartment dosimetry, repeat treatments), resulting in long survival and low AEs. Final results for this study are expected in 2025.PI-1789608-AA*The use of TheraSphere for ICC is outside the labeled indication.
- |||||||||| TheraSphere (yttrium 90 microspheres) / Boston Scientific, SIR-Spheres (yttrium-90 microspheres) / SIRTeX Medical
Journal: Feasibility of Liver Transplantation after 90Y Radioembolization: Lessons from a Radiation Protection Incident. (Pubmed Central) - Mar 27, 2024 This dosimetric study suggests the feasibility of shortening the delay for liver transplantation/surgery after radioembolization from the 8th or 15th day after using SIR-Spheres or TheraSphere, respectively. This delay can be decreased further when adjusted to the administrated activity while upholding radiation protection standards for healthcare professionals.
- |||||||||| TheraSphere (yttrium 90 microspheres) / Boston Scientific, Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion date, Trial termination, Trial primary completion date, Combination therapy: Nivolumab and Yttrium-90 in Treating Patients With Liver Cancer Undergoing Surgical Resection (clinicaltrials.gov) - Feb 21, 2024 P1, N=2, Terminated, In patients with localized, poor prognosis HCC, pembrolizumab in addition to glass Y90 radioembolization demonstrated promising efficacy and safety consistent with prior observations (ClinicalTrials.gov Identifier: NCT03099564; IRB Approved: 16-3255 approved July 12, 2016). Trial completion date: Dec 2022 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Oct 2023; Lack of funding
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Enrollment change: TheraSphere (clinicaltrials.gov) - Jan 8, 2024 P=N/A, N=0, Approved for marketing, Initiation date: Sep 2023 --> Jan 2024 N=186 --> 0
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Journal: Technical Note: Impact of impurities on Yttrium-90 glass microsphere activity quantitation. (Pubmed Central) - Nov 13, 2023 While typical levels of impurities appear to have acceptable impact on patient absorbed dose, it should be noted that they can have adverse effects on Y radioactivity measurements. Furthermore, there is currently minimal independent verification and/or monitoring of impurity levels within the field.
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Trial completion date, Trial primary completion date: MANDARIN (S6371) (clinicaltrials.gov) - Nov 9, 2023 P3, N=90, Recruiting, Furthermore, there is currently minimal independent verification and/or monitoring of impurity levels within the field. Trial completion date: Apr 2026 --> Oct 2026 | Trial primary completion date: Dec 2024 --> Jun 2025
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Trial completion, Trial completion date: TheraSphere Post-Approval Study to Calculate the Radiation-absorbed Dose of Tc-99m MAA. (clinicaltrials.gov) - Oct 31, 2023 P=N/A, N=5, Completed, Trial completion date: Apr 2026 --> Oct 2026 | Trial primary completion date: Dec 2024 --> Jun 2025 Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Jun 2023
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Enrollment closed, Trial completion date, Trial primary completion date: Radioembolization for HCC Patients With Personalized Yttrium-90 Dosimetry for Curative Intent (RAPY90D) (clinicaltrials.gov) - Sep 28, 2023 P=N/A, N=42, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Jun 2023 Unknown status --> Active, not recruiting | Trial completion date: Oct 2021 --> Sep 2024 | Trial primary completion date: Oct 2021 --> Sep 2024
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Trial completion date, Trial primary completion date: ROWAN: TheraSphere With Durvalumab and Tremelimumab for HCC (clinicaltrials.gov) - Aug 22, 2023 P2, N=100, Recruiting, Unknown status --> Active, not recruiting | Trial completion date: Oct 2021 --> Sep 2024 | Trial primary completion date: Oct 2021 --> Sep 2024 Trial completion date: Sep 2027 --> Jun 2027 | Trial primary completion date: Jul 2027 --> Dec 2026
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Enrollment open, Enrollment change, Trial primary completion date: ROWAN: TheraSphere With Durvalumab and Tremelimumab for HCC (clinicaltrials.gov) - Jul 3, 2023 P2, N=100, Recruiting, Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024 Suspended --> Recruiting | N=150 --> 100 | Trial primary completion date: Mar 2027 --> Jul 2027
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Trial completion date: ROWAN: TheraSphere With Durvalumab and Tremelimumab for HCC (clinicaltrials.gov) - May 22, 2023 P2, N=150, Suspended, Trial completion date: May 2023 --> Aug 2023 | Trial primary completion date: May 2023 --> Aug 2023 Trial completion date: May 2028 --> Jul 2027
- |||||||||| TheraSphere (yttrium 90 microspheres) / Boston Scientific, SIR-Spheres (yttrium-90 microspheres) / SIRTeX Medical
Journal: Post-treatment Exposure Rates for Y Microsphere Patients: A Comparison of Products. (Pubmed Central) - Mar 7, 2023 An independent samples t-test analysis (?=0.05) was performed for a total of 50 patients (25 TheraSphere and 25 SIR-Spheres) to determine if the products behaved similarly to the extent that exposure to others is minimized and ALARA principles were kept. The results showed that the products exhibit no significant differences in terms of exposure rates, which suggests that there is no need for unique aspects of one procedure for one product compared to the other.
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Trial completion date, Trial suspension, Trial primary completion date: ROWAN: TheraSphere With Durvalumab and Tremelimumab for HCC (clinicaltrials.gov) - Feb 21, 2023 P2, N=150, Suspended, The results showed that the products exhibit no significant differences in terms of exposure rates, which suggests that there is no need for unique aspects of one procedure for one product compared to the other. Trial completion date: Nov 2026 --> May 2028 | Recruiting --> Suspended | Trial primary completion date: Nov 2026 --> May 2027
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Enrollment open, Combination therapy: Therasphere (clinicaltrials.gov) - Feb 8, 2023 P2, N=84, Recruiting, Dosimetric parameters derived from the retrospective analysis of post-TARE Y-90 bremsstrahlung SPECT/CT after lobar treatment of HCC suggest that volumetric coverage of GTV, not a high mean or median dose, is the driving factor in treatment response and that this is best assessed through the analysis of actual Y-90 biodistribution. Not yet recruiting --> Recruiting
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Trial completion date, Trial primary completion date: MANDARIN (S6371) (clinicaltrials.gov) - Jan 30, 2023 P3, N=90, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Aug 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Dec 2024
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