Dosimetry of Tc-99m-Tilmanocept

NCT05241522 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: DK127201-02
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Standard uptake value in the kidney

  Time until 90% uptake in the kidney measured by SPECT/CT immediately after tilmanocept injection.

  Approximately 1 hour

Study Arms (3)

Tilmanocept Dose - 0.050 mg

ACTIVE COMPARATOR

Diagnostic Test: Tc-99m-Tilmanocept

Tilmanocept Dose - 0.20 mg

ACTIVE COMPARATOR

Diagnostic Test: Tc-99m-Tilmanocept

Tilmanocept Dose - 0.40 mg

ACTIVE COMPARATOR

Diagnostic Test: Tc-99m-Tilmanocept

Interventions

Tc-99m-Tilmanocept DIAGNOSTIC_TEST

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 imaging for differentiating diabetic kidney disease from other causes of kidney disease.

Tilmanocept Dose - 0.050 mg; Tilmanocept Dose - 0.20 mg; Tilmanocept Dose - 0.40 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be required to satisfy the following criteria at the screening visit unless otherwise stated:
• The patient has provided written informed consent with HIPAA (Health Insurance Portability and Accountability Act) authorization before the initiation of any study-related procedures.
• 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
• 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.
• Subjects will have a BMI of 18 to 49.9 kg/m2, inclusive, at screening.
• Meets clinical criteria described in the groups section above.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study.
• The patient is pregnant or lactating.
• The patient has participated in another investigational drug study within 3 months prior to Day 1.
• 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).
• The subject has a Hemoglobin A1c\>10.0
• The subject is on greater than 4 anti-hypertensives or has a a systolic blood pressure at time of screening greater than 160mm Hg.
• The patient has a suspected glomerulonephirtis, not including diabetic nephropathy, or hypertensive nephrosclerosis.
• The subject has a history of significant hypersensitivity, intolerance, or allergy to dextran or modified forms of dextran; unless approved by the Investigator.
• The subject has a history or presence of an acutely abnormal ECG, which, in the Investigator's opinion, is clinically significant.
• The subject has exceeded yearly radioactive dose of 30 mSv.
• The subject has a history of drug abuse or alcohol within 2 years before dose administration.
• The subject has poor peripheral venous access.
• The subject has donated blood within 30 days prior to Day 1, or plasma within 2 weeks prior to Day 1.
• The subject has received blood products within 2 months prior to Day 1.
• The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Carl Hoh, MD

  UC San Diego Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof-hcomp - Radiology

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 15, 2022
• Study Start: August 6, 2021
• Primary Completion: December 1, 2024
• Study Completion: February 28, 2026
• Last Updated: May 5, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)