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New scan could spot kidney damage from diabetes earlier

NCT ID NCT05241522

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This early-phase trial tested a radioactive tracer called Tc-99m-Tilmanocept to see if it can help doctors detect diabetic kidney disease using SPECT/CT scans. The study involved 57 adults with suspected diabetic kidney disease. The goal was to measure how the tracer behaves in the kidneys and whether it can tell diabetic kidney damage apart from other causes. This is not a treatment but a step toward better diagnosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tc-99m-Tilmanocept (a radioactive tracer used for imaging)
What this could lead to
If successful, this imaging method could help doctors diagnose diabetic kidney disease earlier and more accurately, potentially leading to better treatment decisions.
What could go wrong
This is a very early phase 1 study focused on safety and imaging, not treatment. It may not lead to a reliable diagnostic test, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

57 people

The number who actually took part.

Started

Aug 2021

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects will be required to satisfy the following criteria at the screening visit unless otherwise stated: 1. The patient has provided written informed consent with HIPAA (Health Insurance Portability and Accountability Act) authorization before the initiation of any study-related procedures. 2. The patient is at least 18 years of age at the time of consent. 3. The patient has an ECOG performance status of Grade 0 - 2 4. If of childbearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year. 5. Subjects will have a BMI of 18 to 49.9 kg/m2, inclusive, at screening. 6. Meets clinical criteria described in the groups section above. Exclusion Criteria: * Subjects who meet any of the following criteria will be excluded from the study. 1. The patient is pregnant or lactating. 2. The patient has participated in another investigational drug study within 3 months prior to Day 1. 3. The subject has another significant medical condition requiring active surgical or medical intervention whose urgency would preclude participation in this study (active cardiac or pulmonary conditions,; ongoing ischemia or cardiac symptoms, uncorrected CAD or decompensated CHF). 4. The subject has a Hemoglobin A1c\>10.0 5. The subject is on greater than 4 anti-hypertensives or has a a systolic blood pressure at time of screening greater than 160mm Hg. 6. The patient has a suspected glomerulonephirtis, not including diabetic nephropathy, or hypertensive nephrosclerosis. 7. The subject has a history of significant hypersensitivity, intolerance, or allergy to dextran or modified forms of dextran; unless approved by the Investigator. 8. The subject has a history or presence of an acutely abnormal ECG, which, in the Investigator's opinion, is clinically significant. 9. The subject has exceeded yearly radioactive dose of 30 mSv. 10. The subject has a history of drug abuse or alcohol within 2 years before dose administration. 11. The subjects used any prescription medications within 14 days prior to Day 1, except as allowed by the inclusion criteria or as deemed acceptable by the Investigator. 12. The subject has poor peripheral venous access. 13. The subject has donated blood within 30 days prior to Day 1, or plasma within 2 weeks prior to Day 1. 14. The subject has received blood products within 2 months prior to Day 1. 15. The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UC San Diego Medical Center

    San Diego, California, 92103, United States

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