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Diagnostic 68Ga-PSMA-11 PET/CT
Rochester, MN
The purpose of this study is the diagnostic 68Ga-PSMA-11 PET/CT imaging for screening prior to consideration of 177Lu-PSMA-617 therapy.
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A Study to Evaluate Triapine Combined with Lutetium Lu 177 Dotatate for Gastroenteropancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine.
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EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.
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Study of RYZ101 Compared With SOC in Pts With Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, effectiveness, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.
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A Study to Evaluate CHIP and Hematological Toxicity After PRRT in Neuroendocrine Tumor Patients
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to combine robust clinical data (e.g., prior chemotherapy or radiation exposure, cumulative Peptide Receptor Radionuclide Therapy (PRRT dose)) with genetic and clonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in PRRT-treated neuroendocrine tumor (NET) patients.
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A Study of Lutetium Lu 177 Dotatate (Lutathera®) in Patients with Inoperable, Progressive Meningioma after External Beam Radiation Therapy
Rochester, MN
The purpose of this study is to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 1 meningioma as measured by 6-month PFS rate, and to estimate the efficacy of LUTATHERA treatment in patients with recurrent grade 2 or 3 meningioma as measured by 6-month PFS rate.
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Study to Evaluate the Efficacy and Safety of Lutathera in Patients with Grade 2 and Grade 3 Advanced GEP-NET
Rochester, MN
The purpose of this study is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.