Dosimetry of Tc-99m-Tilmanocept (NCT05241522) | Clinical Trial Compass
CompletedPhase 1
Dosimetry of Tc-99m-Tilmanocept
United States57 participantsStarted 2021-08-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.