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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 hour
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Standard uptake value in the kidney
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
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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
1,121 Previous Clinical Trials
1,520,804 Total Patients Enrolled
Carl Hoh, MDPrincipal InvestigatorUC San Diego Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have difficulty with needle insertions due to poor vein access.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I have not received any radiopharmaceuticals in the last 7 days.I am not pregnant, have been sterilized, or have been postmenopausal for over a year.I do not have any urgent health issues that would stop me from joining this study.You have a history of a very abnormal ECG that the doctor thinks is important.You have already received a high amount of radiation in the past year.I haven't taken any prescription drugs in the last 14 days, except those approved by my doctor.You need to have a body mass index (BMI) between 18 and 49.9 to be eligible.I am suspected to have a kidney inflammation not caused by diabetes or high blood pressure.Your Hemoglobin A1c level is higher than 10.0.I have received a blood transfusion within the last 2 months.I have not donated blood or plasma within the restricted time before starting the trial.I take more than 4 blood pressure medications or my blood pressure is over 160.
Research Study Groups:
This trial has the following groups:- Group 1: Tilmanocept Dose - 0.20 mg
- Group 2: Tilmanocept Dose - 0.40 mg
- Group 3: Tilmanocept Dose - 0.050 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in this medical investigation?
"Affirmative. The details provided on clinicaltrials.gov suggest that this medical trial, which was initially listed on August 6th 2021 is still actively recruiting patients for participation. Around 120 individuals must be enrolled from a single site."
Answered by AI
Has the FDA verified the efficacy of Tilmanocept Dose - 0.40 mg?
"Tilmanocept Dose - 0.40 mg safety has only been partially evaluated, thus receiving a score of 1 on our scale from one to three."
Answered by AI
Are there still spots available for participants in this experiment?
"Clinicaltrials.gov confirms that, as of 16th February 2022, this clinical trial is actively recruiting individuals to participate. The study first appeared on 6th August 2021."
Answered by AI
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