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Sphere - ClinicalTrials.gov

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Last Updated: 21 July 2022

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A Phase II Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres (SIR-Spheres®)

Radioembolization using yttrium-90 microspheres is FDA-approved for treating liver metastases from colorectal cancer. Although each of these individual therapies has had promising results, investigators speculate that treatment for patients with NETs can be enhanced by co-administration of both therapies. The treating radiation oncologist will determine the dose and treatment day of SIR-Spheres. Patients who are currently or have ever received lanreotide are eligible, and lanreotide therapy can continue monthly until disease progression or unacceptable toxicity.

Source link: https://clinicaltrials.gov/ct2/show/NCT02859064


A Prospective, Multicenter, Open-label Single Arm Study Evaluating the Safety & Efficacy of Selective Internal Radiation Therapy Using SIR-Spheres® Y-90 Resin Microspheres on DoR & ORR in Unresectable Hepatocellular Carcinoma Patients

Patients with HCC BCLC stage A, B1, B2, and C with maximum single lesion size of u2264 8 cm and are not considered eligible for ablation at the time of study enrollment include patients with HCC BCLC stage A, B1, B2, and C with maximal single lesion size of u2264 8 cm and are not considered suitable for treatment by resection or ablation at the time of study enrollment.

Source link: https://clinicaltrials.gov/ct2/show/NCT04736121


An Acceptability Study to Evaluate the Tolerance, Adherence and Metabolic Control of Patients With Phenylketonuria (PKU) Consuming PKU Sphere™, a Glycomacropeptide (GMP) Based Protein Substitute, When Introduced According to a Practical Guide to PKU Sphere.

PKU spheres will be introduced into their diet by 20 people with phenylketonuria. Participants will test their phenylalanine and tyrosine levels twice a week in order for their health care practitioner to track their phenylalanine and tyrosine levels. After three straight dried blood spot results within the target range, the participant's HCP will be able to recommend swapping one portion of amino acid-based protein substitute for PKU sphere. Vitaflo's 'Practical Guide to PKU's Sphere' explains this method of increasing the amount of PKU sphere to be taken directly. ' The amount of PKU sphere taken each day by the participant in their research diary is determined by the participant. The participant or after 16 weeks of being enrolled in the four-week Evaluation Period is expected to receive the maximum recommended amount of PKU sphere. Participants now visit a dried blood spot once a week, but they also log their intake of PKU sphere each day. Participants will also share their thoughts on the PKU sphere's palatability at the end of Evaluation Period weeks two and four. Participants are returning to the clinic for the End of Study visit at the conclusion of the Evaluation Period. The PKU and GI specific questionnaires completed at Baseline are all repeated, and the Investigator addresses the participant's ability to continue to take PKU and GI specific medications as part of their regular therapeutic diet. Following their End of Study Visit, a follow-up phone call would relay the findings of any outstanding dried blood spot research to participants.

Source link: https://clinicaltrials.gov/ct2/show/NCT04679467

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions