Trials / Completed
CompletedNCT05785663
AminoMedixTM for Kidney Protection During Radionuclide Therapy
AminoMedixTM for Radiation Kidney Protection During Peptide-Receptor Radionuclide Therapy (PRRT): Phase I, II Clinical Trial
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 28 (actual)
- Sponsor
- Excel Diagnostics and Nuclear Oncology Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I, and II, single-center, open-label clinical trial to evaluate the safety and preliminary efficacy information of AminoMedix™ in protecting kidneys from radiation-induced toxicity during Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers. Aims of the study: 1. Evaluation of the safety of AminoMedix ™ infusion. 2. Evaluation of kidney radiation dosimetry with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE. 3. Evaluation of the safety and calculation of kidney and tumor radiation dosimetry after AminoMedix™ infusion with low dose 177Lu-DOTATATE in patients with neuroendocrine cancers.
Conditions
Timeline
- Start date
- 2014-08-08
- Primary completion
- 2016-09-28
- Completion
- 2020-03-17
- First posted
- 2023-03-27
- Last updated
- 2023-03-27
Source: ClinicalTrials.gov record NCT05785663. Inclusion in this directory is not an endorsement.