Dosimetry of Tc-99m-Tilmanocept

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.

Eligibility

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.

Conditions2

Locations1 site

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