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RECRUITING
NCT05241522
PHASE1

Dosimetry of Tc-99m-Tilmanocept

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-08-06

Completion Date

2024-12-31

Last Updated

2024-05-07

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Tc-99m-Tilmanocept

Administration of 3 different doses of Tc-99m-Tilmanocept prior to SPECT-CT imaging of the kidney in order to determine the safety and efficacy of tilmanocept imaging for differentiating diabetic kidney disease from other causes of kidney disease.

Locations (1)

UC San Diego Medical Center

San Diego, California, United States