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Tc-99m-Tilmanocept Imaging for Diabetic Kidney Disease

Phase 1
Recruiting
Led By Carl Hoh, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
The subject has poor peripheral venous access.
The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 hour
Awards & highlights
No Placebo-Only Group

Summary

This trial will use a SPECT/CT scan of the kidneys using Tc-99m-tilmanocept to look for changes in the kidneys of diabetics that could indicate different stages of kidney disease.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include allergic reactions due to hypersensitivity towards dextran or modified forms of it as used in Tc-99m-Tilmanocept; however specific side effects are not listed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have difficulty with needle insertions due to poor vein access.
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I have not received any radiopharmaceuticals in the last 7 days.
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I do not have any urgent health issues that would stop me from joining this study.
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I am suspected to have a kidney inflammation not caused by diabetes or high blood pressure.
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I take more than 4 blood pressure medications or my blood pressure is over 160.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Standard uptake value in the kidney

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Tilmanocept Dose - 0.20 mgActive Control1 Intervention
Group II: Tilmanocept Dose - 0.40 mgActive Control1 Intervention
Group III: Tilmanocept Dose - 0.050 mgActive Control1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,927 Total Patients Enrolled
Carl Hoh, MDPrincipal InvestigatorUC San Diego Medical Center

Media Library

Tilmanocept Dose - 0.20 mg Clinical Trial Eligibility Overview. Trial Name: NCT05241522 — Phase 1
Diabetic Kidney Disease Research Study Groups: Tilmanocept Dose - 0.20 mg, Tilmanocept Dose - 0.40 mg, Tilmanocept Dose - 0.050 mg
Diabetic Kidney Disease Clinical Trial 2023: Tilmanocept Dose - 0.20 mg Highlights & Side Effects. Trial Name: NCT05241522 — Phase 1
Tilmanocept Dose - 0.20 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05241522 — Phase 1
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