A Phase 1, Open-Label Study to Investigate the Dosimetry of Tc-99m-Tilmanocept Following a Single Intravenous Dose Administration in Women and Men Suspected of Diabetic Nephropathy.
This proposal will use kidney SPECT/CT of Tc-99m-tilmanocept to evaluate the mesangial changes seen in diabetics across the spectrum of kidney disease as well as persons with hypertensive kidney disease, the next most common cause of kidney disease in patients with diabetes. We aim to demonstrate that these different disease types and stages can be differentiated with Tc-99m-tilmanocept SPECT/CT and can thus be used for future trials evaluating early diagnosis and treatment of diabetic nephropathy.
• Subjects will be required to satisfy the following criteria at the screening visit unless otherwise stated:
‣ The patient has provided written informed consent with HIPAA (Health Insurance Portability and Accountability Act) authorization before the initiation of any study-related procedures.
⁃ The patient is at least 18 years of age at the time of consent.
⁃ The patient has an ECOG performance status of Grade 0 - 2
⁃ If of childbearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
⁃ Subjects will have a BMI of 18 to 49.9 kg/m2, inclusive, at screening.
⁃ Meets clinical criteria described in the groups section above.