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.
Study Type
OBSERVATIONAL
Enrollment
28
Evaluation of kidney radiation dosimetry in subjects with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE™
Dosimetry results of 68Ga-DOTATATE in subjects, with and without AminoMedixTM will be compared. Each Subject will be imaged with and without AminoMedixTM 24 hours to 3 weeks apart and the reduction ratio will be calculated
Time frame: 24 hours to 3 weeks between two dosimetry
Frequency and Severity of Adverse Events after AminoMedix™ infusion
Frequency and severity of treatment-related adverse events as assessed by CTCAE v4.0" in subjects after AminoMedix™ infusion
Time frame: Subjects will be followed for two weeks following administration of AminoMedix™
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