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Recruiting Phase 1 NCT05241522

Dosimetry of Tc-99m-Tilmanocept

Trial Parameters

Condition Diabetic Kidney Disease
Sponsor University of California, San Diego
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-08-06
Completion 2024-12-01
Interventions
Tc-99m-Tilmanocept

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Subjects will be required to satisfy the following criteria at the screening visit unless otherwise stated: 1. The patient has provided written informed consent with HIPAA (Health Insurance Portability and Accountability Act) authorization before the initiation of any study-related procedures. 2. The patient is at least 18 years of age at the time of consent. 3. The patient has an ECOG performance status of Grade 0 - 2 4. 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. 5. Subjects will have a BMI of 18 to 49.9 kg/m2, inclusive, at screening. 6. Meets clinical criteria described in the groups section above. Exclusion Criteria: * Subjects who meet any of the following criteria will be excluded from the study. 1. The patient is pregnant or lactating. 2. The patient has participated in another investigational dr

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