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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the special imaging agent Tc-99m-Tilmanocept can identify different stages and types of kidney disease in people with diabetes. The researchers seek to determine if this imaging method can effectively differentiate between diabetic kidney disease and kidney disease caused by high blood pressure. Participants will receive varying doses of the imaging agent to test its effectiveness. Individuals with diabetes and kidney issues, possibly related to high blood pressure, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative imaging agent.

Do I need to stop taking my current medications for the trial?

Yes, you must stop taking any prescription medications 14 days before the trial starts, unless the trial allows it or the investigator approves it.

Is there any evidence suggesting that Tc-99m-Tilmanocept is likely to be safe for humans?

Research has shown that Tc-99m-Tilmanocept, the treatment used in this trial, has been studied for safety in humans. Although specific side effects are not listed in the available information, this trial remains in an early stage, so researchers are still carefully checking safety. Early-stage trials focus on how well a treatment is tolerated and any possible side effects.

Tc-99m-Tilmanocept is a radiotracer, a substance used in imaging to observe how certain parts of the body function. It is generally used in small amounts, which can lower the risk of side effects. However, since specific side effect data is not available, it's important to remember that researchers are still collecting safety information.

Participants considering joining the trial should feel reassured that these studies are designed to ensure the treatment is as safe as possible before moving to later stages involving more people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for diabetic kidney disease focus on managing blood sugar and blood pressure to slow down kidney damage. However, Tc-99m-Tilmanocept is unique because it uses a radiotracer to specifically target and highlight inflammation in the kidneys, which can be an early sign of diabetic kidney disease. This innovative approach allows for precise imaging of kidney health, potentially enabling earlier detection and more tailored treatment strategies. Researchers are excited because this could lead to timely interventions that address the root cause of kidney damage in diabetics, rather than just managing symptoms.

What evidence suggests that Tc-99m-Tilmanocept imaging is effective for diabetic kidney disease?

Research shows that Tc-99m-tilmanocept can aid in imaging diabetic kidney disease. In earlier studies, it highlighted changes in the kidneys of diabetic patients using a special scan called SPECT/CT. This scan enables doctors to observe how the disease affects the kidney's tiny filtering parts, known as mesangial cells. Early results suggest that Tc-99m-tilmanocept enhances the visibility of these changes, which could assist in early diagnosis. This trial will test various doses of Tc-99m-tilmanocept to assess its effectiveness in identifying different types and stages of kidney disease, potentially leading to improved treatments. ^{1 2 3 6 7}

Who Is on the Research Team?

Carl Hoh, MD

Principal Investigator

UC San Diego Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05241522

NCT05241522 | Dosimetry of Tc-99m-Tilmanocept 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05241522?term=TECHNETIUM%20TC-99M%20TILMANOCEPT&viewType=Table&rank=2

NCT05241522 | Dosimetry of 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 ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/482216

Dosimetry of Tc-99m-Tilmanocept 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 ...

4. navidea.com navidea.com/news-media/press-releases/detail/373/navidea-biopharmaceuticals-announces-nih-grant-award-to-uc

Press Releases In this Phase 1 clinical study being conducted at UC San Diego Health, Tc99m tilmanocept will be used as an imaging agent to evaluate a key ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6910642/

Molecular Imaging of the Glomerulus via Mesangial Cell ... The renal %ID/g of 99mTc-labeled Cy5-tilmanocept by nondiabetic db/m mice far exceeded the renal accumulation of the diabetic db/db mice at all 3 ages. The %ID ...

6. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/diabetes

UCSD Diabetes Clinical Trials for 2025 — San Diego This proposal will use kidney SPECT/CT of Tc-99m-tilmanocept to ... safety data on Control-IQ technology v1.5 in children with type 1 ...

7. reporter.nih.gov reporter.nih.gov/project-details/11066521

Genetic risk and molecular characterization of Diabetic ... Our data show Xor expression and activity was strongly increased by diabetes in glomeruli of DBA/2J, but not C57BL/6J resistant mice. A functional role for Xor ...