RECRUITING

Dosimetry of Tc-99m-Tilmanocept

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-Label Study to Investigate the Dosimetry of Tc-99m-Tilmanocept Following a Single Intravenous Dose Administration in Women and Men Suspected of Diabetic Nephropathy.

Quick Facts

Study Start:2021-08-06

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05241522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Carl Hoh, MD

CONTACT

8582493286

ckhoh@health.ucsd.edu

Principal Investigator

Carl Hoh, MD

PRINCIPAL_INVESTIGATOR

UC San Diego Medical Center

Study Locations (Sites)

UC San Diego Medical Center

San Diego, California, 92103

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Carl Hoh, MD, PRINCIPAL_INVESTIGATOR, UC San Diego Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-06

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2021-08-06

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Diabetic Kidney Disease