Tc-99m-Tilmanocept Imaging for Diabetic Kidney Disease

Overseen By Carl Hoh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Diego

Must not be taking: Prescription medications

Disqualifiers: Pregnancy, Cardiac conditions, High HbA1c, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Carl Hoh, MD

Principal Investigator

UC San Diego Medical Center

Eligibility Criteria

Adults over 18 with kidney disease, specifically diabetic or hypertensive kidney disease, can join this trial. They must consent to the study and not be pregnant or trying to conceive. Participants should have a stable health status (ECOG Grade 0-2) and a BMI between 18-49.9 kg/m2. Exclusions include recent drug/alcohol abuse, high radiation exposure, participation in other trials within 3 months, significant allergies to dextran, certain medication use prior to the trial start date, poor vein access for injections.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

The patient has provided written informed consent with HIPAA (Health Insurance Portability and Accountability Act) authorization before the initiation of any study-related procedures.

I am not pregnant, have been sterilized, or have been postmenopausal for over a year.

Exclusion Criteria

The subject has a history of significant hypersensitivity, intolerance, or allergy to dextran or modified forms of dextran; unless approved by the Investigator.

I have difficulty with needle insertions due to poor vein access.

The patient is pregnant or lactating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Baseline and Treatment

Participants receive IV administration of Tc-99m-tilmanocept and undergo imaging procedures

1 day

1 visit (in-person)

Immediate Follow-up

Participants are monitored for adverse events and undergo additional imaging and laboratory evaluations

1 day

1 visit (in-person)

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

5-7 days

1 visit (in-person)

Treatment Details

Interventions

• Tc-99m-Tilmanocept

Trial Overview The trial is testing Tc-99m-Tilmanocept using SPECT/CT imaging to detect mesangial changes in kidneys affected by diabetes or hypertension. The goal is to see if this method can differentiate stages of kidney disease and help diagnose diabetic nephropathy early on.

Participant Groups

Group I: Tilmanocept Dose - 0.20 mg Active Control 1 Intervention

Group II: Tilmanocept Dose - 0.40 mg Active Control 1 Intervention

Group III: Tilmanocept Dose - 0.050 mg Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+